Regulatory Specialist Jobs
Regulatory Specialist jobs are open from entry-level to senior and principal across pharmaceuticals, medical devices, financial services, and energy, with specializations in FDA compliance, environmental regulation, and product submissions. Scan the live roles below and apply to whichever ones fit.
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Looking for a way to make an impact and help people?
Join PacificSource and help our members access quality, affordable care!
PacificSource is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status, such as race, religion, color, sex, sexual orientation, gender identity, national origin, genetic information or age. PacificSource values the diversity of our community, including those we hire and serve. We are committed to creating and fostering a work environment in which individual differences and diversity are appreciated, respected and responded to in ways that fully develop and utilize each person’s talents and strengths.
Support all aspects of Health Services (Appeals and Grievances, Case Management, Utilization Management, and Medical Pharmacy) compliance by assuming a primary role in monitoring and reporting on Health Services operational activities and delegated functions. Collaborate with Health Services leadership and Compliance to oversee regulatory and delegated functions pertaining to Health Services. Maintain working knowledge of applicable Federal, State, industry, and organizational rules, regulations, standards, and contract language; conduct and participate in internal and external audits; and identify, investigate, and follow up on potential issues or opportunities for improvement. Assist in the creation and maintenance of compliant policies and procedures, member and provider letters and materials, and employee resources. In conjunction with the leadership and training teams, assist with the development of employee education/orientation programs that will encompass onboarding new employees as well as continuing education for all Health Services staff as applies to regulations.Essential Responsibilities:
- Collaborate with Health Services leadership and Compliance to develop and conduct internal audits to assess and ensure compliance with Federal, State, organizational, and industry rules, regulations, and standards.
- Perform routine and ad hoc monitoring activities of Health Services operations to ensure compliance with applicable rules, regulations, and standards; report findings to Health Services leadership, Compliance, and appropriate internal committees as necessary.
- Perform delegation oversight activities of applicable vendors to ensure delegated functions are complying with applicable rules and regulations and meeting service agreement performance standards, report findings to Health Services leadership and applicable internal committees.
- Conduct at least monthly monitoring of staff, including vendors and sub-contractors, who are involved in utilization management decision-making to ensure consistency with application of clinical policies (i.e., care guidelines, clinical criteria) and compliance with required processing timeframes.
- Serve as liaison between Health Services, Compliance, and Fraud, Waste, and Abuse (FWA) teams with identifying, reporting, and, as assigned, investigating FWA cases.
- Maintain a current working knowledge of State contract language and all applicable Federal, State, organizational, and industry rules, regulations, standards, and best-practices; provide assessment, interpretation, impact reporting, and training on new and revised rules, regulations, and requirements.
- Collaborate with Health Services leadership, regulatory and reporting staff, and Compliance to respond to all compliance-related inquiries from internal and external auditors in a timely, professional, and accurate manner to ensure minimal organizational and operational impact
- Oversee, prepare, present, submit required reporting to Federal, State, and industry agencies (e.g., quarterly utilization management (UM) reports to Oregon Health Authority (OHA)) and organizational committees (e.g., trending and data reports to Clinical Quality and Utilization Management (CQUM) committee).
- Attend and actively participate as presenter or Health Services representative in internal and external meetings, committees, and audits as assigned.
- Utilize LEAN methodologies and quality improvement principles to practice and promote continuous improvement; utilize visual boards and daily huddles to monitor and communicate key performance indicators (KPI) and identify opportunities for improvement and evaluation of actions taken
- Participate in routine monitoring of internal documents and materials, including but not limited to policies and procedures, desk top references, training materials, member and provider letters and handbooks, and create or revise accordingly and in collaboration with other internal communities to ensure compliance with applicable rules, regulations, and standards and alignment with organizational branding.
- Contribute to and support the implementation and maintenance of an employee education program that encompasses new and existing employee, vendor and subcontractor onboarding, that addresses operational and regulatory requirements and updates, and pertains to practices relevant to Health Services.
Supporting Responsibilities:
- Act as backup for other Health Services department staff as needed and within scope of licensure.
- Serve on designated committees, teams, and task groups, as directed.
- Represent the Heath Services department, both internally and externally, as requested by Medical Director and Health Services leadership.
- Meet department and company performance and attendance expectations.
- Follow the PacificSource privacy policy and HIPAA laws and regulations concerning confidentiality and security of protected health information.
- Perform other duties as assigned.
SUCCESS PROFILE
Work Experience:
A minimum of six years nursing or clinical behavioral health experience with varied health care exposure and experience required. A minimum 2 years insurance industry experience required. Demonstrated knowledge and experience with program development and auditing preferred.
Education, Certificates, Licenses:
Registered Nurse; Licensed Clinical Psychologist, Licensed Clinical Social Worker, or comparable behavioral health professional with extensive experience and/or credentials (e.g., Licensed Professional Counselor, Licensed Marriage and Family Therapist, Psychiatric Mental Health Nurse Practitioner). Current unrestricted state license(s). Within 2 years in this position, obtain Certified Case Manager (CCM) as accredited by CCMC (The Commission for Case Management Certification) preferred, or 60 CEUs in Utilization Management areas of focus.
Knowledge:
Thorough knowledge and understanding of medical procedures, diagnoses, care modalities, procedure codes including ICD-10, DSM-IV, and CPT Codes, health insurance and State-mandated benefits. Thorough knowledge and understanding of options available within and without contractual benefits. Ability to use computerized systems for data recording and retrieval. Assures patient confidentiality, privacy, and health records security. Proficient in the use and implementation of the following tools and concepts across all teams within scope of accountability: strategy deployment, daily operations, visual management, operational improvement, auditing. Establishes and maintains relationships with internal and external customers. Maintains current clinical knowledge base and certification. Ability to work independently with minimal supervision and collaboratively in a team as indicated.
Competencies:
Adaptability
Building Customer Loyalty
Building Strategic Work Relationships
Building Trust
Continuous Improvement
Contributing to Team Success
Planning and Organizing
Work Standards
Environment:
Work inside in a general office setting with ergonomically configured equipment. Travel is required approximately 10% of the time.
Skills:
Accountability, Collaboration, Communication (written/verbal), Flexibility, Listening (active), Organizational skills/Planning and Organization, Problem Solving, TeamworkCompensation Disclaimer
The wage range provided reflects the full range for this position. The maximum amount listed represents the highest possible salary for the role and should not be interpreted as a typical starting wage. Actual compensation will be determined based on factors such as qualifications, experience, education, and internal equity. Please note that the stated range is for informational purposes only and does not constitute a guarantee of any specific salary within that range.
Base Range:
$70,950.00 - $106,424.99Our Values
We live and breathe our values. In fact, our culture is driven by these seven core values which guide us in how we do business:
We are committed to doing the right thing.
We are one team working toward a common goal.
We are each responsible for customer service.
We practice open communication at all levels of the company to foster individual, team and company growth.
We actively participate in efforts to improve our many communities-internally and externally.
We actively work to advance social justice, equity, diversity and inclusion in our workplace, the healthcare system and community.
We encourage creativity, innovation, and the pursuit of excellence.
Physical Requirements: Stoop and bend. Sit and/or stand for extended periods of time while performing core job functions. Repetitive motions to include typing, sorting and filing. Light lifting and carrying of files and business materials. Ability to read and comprehend both written and spoken English. Communicate clearly and effectively.
Disclaimer: This job description indicates the general nature and level of work performed by employees within this position and is subject to change. It is not designed to contain or be interpreted as a comprehensive list of all duties, responsibilities, and qualifications required of employees assigned to this position. Employment remains AT-WILL at all times.
Looking for a way to make an impact and help people?
Join PacificSource and help our members access quality, affordable care!
PacificSource is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status, such as race, religion, color, sex, sexual orientation, gender identity, national origin, genetic information or age. PacificSource values the diversity of our community, including those we hire and serve. We are committed to creating and fostering a work environment in which individual differences and diversity are appreciated, respected and responded to in ways that fully develop and utilize each person’s talents and strengths.
Support all aspects of Health Services (Appeals and Grievances, Case Management, Utilization Management, and Medical Pharmacy) compliance by assuming a primary role in monitoring and reporting on Health Services operational activities and delegated functions. Collaborate with Health Services leadership and Compliance to oversee regulatory and delegated functions pertaining to Health Services. Maintain working knowledge of applicable Federal, State, industry, and organizational rules, regulations, standards, and contract language; conduct and participate in internal and external audits; and identify, investigate, and follow up on potential issues or opportunities for improvement. Assist in the creation and maintenance of compliant policies and procedures, member and provider letters and materials, and employee resources. In conjunction with the leadership and training teams, assist with the development of employee education/orientation programs that will encompass onboarding new employees as well as continuing education for all Health Services staff as applies to regulations.Essential Responsibilities:
- Collaborate with Health Services leadership and Compliance to develop and conduct internal audits to assess and ensure compliance with Federal, State, organizational, and industry rules, regulations, and standards.
- Perform routine and ad hoc monitoring activities of Health Services operations to ensure compliance with applicable rules, regulations, and standards; report findings to Health Services leadership, Compliance, and appropriate internal committees as necessary.
- Perform delegation oversight activities of applicable vendors to ensure delegated functions are complying with applicable rules and regulations and meeting service agreement performance standards, report findings to Health Services leadership and applicable internal committees.
- Conduct at least monthly monitoring of staff, including vendors and sub-contractors, who are involved in utilization management decision-making to ensure consistency with application of clinical policies (i.e., care guidelines, clinical criteria) and compliance with required processing timeframes.
- Serve as liaison between Health Services, Compliance, and Fraud, Waste, and Abuse (FWA) teams with identifying, reporting, and, as assigned, investigating FWA cases.
- Maintain a current working knowledge of State contract language and all applicable Federal, State, organizational, and industry rules, regulations, standards, and best-practices; provide assessment, interpretation, impact reporting, and training on new and revised rules, regulations, and requirements.
- Collaborate with Health Services leadership, regulatory and reporting staff, and Compliance to respond to all compliance-related inquiries from internal and external auditors in a timely, professional, and accurate manner to ensure minimal organizational and operational impact
- Oversee, prepare, present, submit required reporting to Federal, State, and industry agencies (e.g., quarterly utilization management (UM) reports to Oregon Health Authority (OHA)) and organizational committees (e.g., trending and data reports to Clinical Quality and Utilization Management (CQUM) committee).
- Attend and actively participate as presenter or Health Services representative in internal and external meetings, committees, and audits as assigned.
- Utilize LEAN methodologies and quality improvement principles to practice and promote continuous improvement; utilize visual boards and daily huddles to monitor and communicate key performance indicators (KPI) and identify opportunities for improvement and evaluation of actions taken
- Participate in routine monitoring of internal documents and materials, including but not limited to policies and procedures, desk top references, training materials, member and provider letters and handbooks, and create or revise accordingly and in collaboration with other internal communities to ensure compliance with applicable rules, regulations, and standards and alignment with organizational branding.
- Contribute to and support the implementation and maintenance of an employee education program that encompasses new and existing employee, vendor and subcontractor onboarding, that addresses operational and regulatory requirements and updates, and pertains to practices relevant to Health Services.
Supporting Responsibilities:
- Act as backup for other Health Services department staff as needed and within scope of licensure.
- Serve on designated committees, teams, and task groups, as directed.
- Represent the Heath Services department, both internally and externally, as requested by Medical Director and Health Services leadership.
- Meet department and company performance and attendance expectations.
- Follow the PacificSource privacy policy and HIPAA laws and regulations concerning confidentiality and security of protected health information.
- Perform other duties as assigned.
SUCCESS PROFILE
Work Experience:
A minimum of six years nursing or clinical behavioral health experience with varied health care exposure and experience required. A minimum 2 years insurance industry experience required. Demonstrated knowledge and experience with program development and auditing preferred.
Education, Certificates, Licenses:
Registered Nurse; Licensed Clinical Psychologist, Licensed Clinical Social Worker, or comparable behavioral health professional with extensive experience and/or credentials (e.g., Licensed Professional Counselor, Licensed Marriage and Family Therapist, Psychiatric Mental Health Nurse Practitioner). Current unrestricted state license(s). Within 2 years in this position, obtain Certified Case Manager (CCM) as accredited by CCMC (The Commission for Case Management Certification) preferred, or 60 CEUs in Utilization Management areas of focus.
Knowledge:
Thorough knowledge and understanding of medical procedures, diagnoses, care modalities, procedure codes including ICD-10, DSM-IV, and CPT Codes, health insurance and State-mandated benefits. Thorough knowledge and understanding of options available within and without contractual benefits. Ability to use computerized systems for data recording and retrieval. Assures patient confidentiality, privacy, and health records security. Proficient in the use and implementation of the following tools and concepts across all teams within scope of accountability: strategy deployment, daily operations, visual management, operational improvement, auditing. Establishes and maintains relationships with internal and external customers. Maintains current clinical knowledge base and certification. Ability to work independently with minimal supervision and collaboratively in a team as indicated.
Competencies:
Adaptability
Building Customer Loyalty
Building Strategic Work Relationships
Building Trust
Continuous Improvement
Contributing to Team Success
Planning and Organizing
Work Standards
Environment:
Work inside in a general office setting with ergonomically configured equipment. Travel is required approximately 10% of the time.
Skills:
Accountability, Collaboration, Communication (written/verbal), Flexibility, Listening (active), Organizational skills/Planning and Organization, Problem Solving, TeamworkCompensation Disclaimer
The wage range provided reflects the full range for this position. The maximum amount listed represents the highest possible salary for the role and should not be interpreted as a typical starting wage. Actual compensation will be determined based on factors such as qualifications, experience, education, and internal equity. Please note that the stated range is for informational purposes only and does not constitute a guarantee of any specific salary within that range.
Base Range:
$70,950.00 - $106,424.99Our Values
We live and breathe our values. In fact, our culture is driven by these seven core values which guide us in how we do business:
We are committed to doing the right thing.
We are one team working toward a common goal.
We are each responsible for customer service.
We practice open communication at all levels of the company to foster individual, team and company growth.
We actively participate in efforts to improve our many communities-internally and externally.
We actively work to advance social justice, equity, diversity and inclusion in our workplace, the healthcare system and community.
We encourage creativity, innovation, and the pursuit of excellence.
Physical Requirements: Stoop and bend. Sit and/or stand for extended periods of time while performing core job functions. Repetitive motions to include typing, sorting and filing. Light lifting and carrying of files and business materials. Ability to read and comprehend both written and spoken English. Communicate clearly and effectively.
Disclaimer: This job description indicates the general nature and level of work performed by employees within this position and is subject to change. It is not designed to contain or be interpreted as a comprehensive list of all duties, responsibilities, and qualifications required of employees assigned to this position. Employment remains AT-WILL at all times.
See All 332+ Regulatory Specialist Jobs
Find roles that match your experience and apply in just a few clicks.
Find Regulatory Specialist JobsRegulatory Specialist Job Market
Who's Hiring
- Katalyst Healthcares & Life Sciences14
- Abbott11
- BD8
- Coloplast8
- Environmental Research6E
Top Industries Hiring
- Medical Devices
- Biotechnology & Pharmaceuticals
- Technology & Software
- Consulting & Professional Services
- Education
What Employers Look For
The qualifications that appear most often in regulatory specialist jobs.
- Bachelor's degree in life sciences, chemistry, engineering, or a related technical field
- Experience preparing and submitting regulatory filings such as 510(k), NDA, or BLA documents
- Working knowledge of FDA regulations including 21 CFR and applicable GxP guidelines
- Proficiency with regulatory information management systems and document control platforms
- Strong written communication skills for drafting submissions, SOPs, and regulatory responses
- Regulatory Affairs Certification (RAC) from RAPS or equivalent credential preferred
Tips for Your Regulatory Specialist Job Search
Tailor your resume to each regulatory framework
FDA submissions look nothing like SEC compliance work, so position your resume around the specific framework each job targets. Naming the exact regulations you've worked under, such as 21 CFR Part 11 or REACH, tells hiring managers you can hit the ground running.
List every relevant certification prominently
Credentials like RAC from RAPS or CRC from ACRC carry real weight in regulatory hiring. Put them in a dedicated section at the top of your resume rather than burying them in a skills list, since many hiring managers screen for them before reading anything else.
Apply early to roles that fit
Migrate Mate lists regulatory specialist openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Target postings by regulatory pathway not industry
Searching by industry alone misses roles where your expertise actually transfers. If you have FDA premarket experience, search terms like '510(k)', 'PMA', or 'regulatory submissions' will surface relevant openings across medical devices, diagnostics, and combination products that a broad industry filter would exclude.
Prepare for scenario-based interview questions
Regulatory interviews frequently involve real submission or compliance scenarios, not just background questions. Practice walking through how you'd handle a CAPAinvestigation, a labeling discrepancy, or an unexpected agency request, so you can answer with a structured, evidence-based response rather than a general one.
Negotiate your title alongside your offer
Regulatory titles vary widely across companies, and a 'Specialist' at one organization may carry 'Manager' responsibilities at another. When you receive an offer, confirm that your title reflects your scope of work, since a misaligned title can affect your positioning in future applications.
Regulatory Specialist Jobs: Frequently Asked Questions
Which companies are hiring the most regulatory specialists?
Katalyst Healthcares & Life Sciences, Abbott, and BD are hiring the most regulatory specialists right now, with openings concentrated in California, Texas, and Minnesota, based on current listings on Migrate Mate as of November 2026. Demand is especially strong in pharmaceutical and medical device companies with active product pipelines.
How many regulatory specialist jobs are remote?
About 70% of regulatory specialist openings are fully remote or hybrid as of November 2026, with remote availability highest in regulatory affairs roles focused on submissions writing, labeling review, and policy analysis. Roles requiring hands-on involvement with manufacturing facilities, laboratory operations, or on-site inspections are more likely to require in-person presence.
How do you become a regulatory specialist?
Start with a bachelor's degree in a technical field such as biology, chemistry, pharmacy, or engineering. Gain foundational experience through quality assurance, clinical operations, or laboratory roles where you encounter regulatory documentation directly. Pursue a Regulatory Affairs Certification from RAPS to formalize your credentials. Build specialized knowledge in one regulatory pathway, such as FDA medical device submissions or pharmaceutical CMC, before broadening into other areas.
How do you get hired as a regulatory specialist with little experience?
Entry points into regulatory work often come through adjacent roles in quality assurance, document control, or clinical data management, where you handle the same submissions and SOPs regulatory teams produce. Volunteer for regulatory projects in your current role, take RAPS continuing education courses to build vocabulary and framework knowledge, and apply to associate or coordinator-level regulatory titles that explicitly mention training for candidates from adjacent functions.
What does the regulatory specialist interview process look like?
Most regulatory specialist interviews run two to four rounds. The first is typically a recruiter screen covering your background and submission experience. A hiring manager interview follows, often including scenario questions about how you'd handle an agency query or a labeling discrepancy. Final rounds may involve a panel with regulatory leadership or a brief writing exercise to assess your ability to draft a summary document or regulatory response clearly and accurately.
Where can I find and apply to regulatory specialist jobs?
You can find and apply to regulatory specialist jobs on Migrate Mate, which lists current openings from across the United States. Search for roles that match your background in pharmaceuticals, medical devices, financial services, or environmental compliance, and apply directly to each listing that fits your experience and target industry.
See All 332+ Regulatory Specialist Jobs
Find roles that match your experience and apply in just a few clicks.
Find Regulatory Specialist Jobs