Entry Level Regulatory Affairs Analyst Jobs
New grad regulatory affairs analyst jobs welcome recent graduates and entry level candidates with zero to two years of experience, where strong internship work or coursework in life sciences, quality, or compliance can matter more than a long resume. Most openings mix on-site, remote, and hybrid settings across Biotechnology & Pharmaceuticals, Medical Devices, and Insurance, with employers like Oscar Health, Abbott, and Dentsply Sirona hiring at this level now.
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Showing 5 of 44+ Entry Level Regulatory Affairs Analyst jobs
INTRODUCTION
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
THE OPPORTUNITY
The Principal RA Specialist will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
This is an exciting opportunity with responsibilities for leading global regulatory submissions, which include but not limited to premarket submissions, pre-submissions and clinical trial applications, which include medical hardware and digital health technology solutions to address the spectrum of customer needs.
This individual has department level influence with experience in US/EU/global submissions and on-market changes and is generally recognized as an expert resource both within Abbott and externally. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
WHAT YOU’LL WORK ON
- Develop global regulatory strategies for product development and planning throughout the product lifecycle.
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
- Provide technical leadership and strategic input on complex issues and to business units.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Create project plans and timelines.
- Lead functional groups in the development of relevant data to complete a regulatory submission.
- Write and edit technical documents.
- Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
- Negotiate with regulatory authorities during the development and review process to ensure submission approval.
- Review and approve labeling to ensure compliance.
- Monitor emerging issues and identify solutions.
- Negotiate internally and externally with regulatory agencies.
- Evaluate regulatory risks of corporate policies.
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
- Ensure compliance with product post-marketing approval requirements.
- Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
- Actively contribute to the development and functioning of the crisis/issue management program.
- Analyze product-associated problems and develop proposals for solutions.
- Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications.
REQUIRED QUALIFICATIONS
- Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications).
- Experienced in regulatory submissions for In Vitro Diagnostic Devices and/or Medical Devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Device Regulation (2017/745) and/or the In Vitro Diagnostic Regulation (IVDR 2017/746).
PREFERRED QUALIFICATIONS
- 5 years’ experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus.
- Experience with either 510(k) applications, PMA supplements, US Device Regulations, or with EU and other International Medical Device Regulations and Submissions.
- Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical investigations, ICH guidelines.
- Experience with word processing, spreadsheet and presentation graphic software packages.
- Experience working in a broader enterprise/cross-division business unit model.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Ability to identify, solve problems, and work independently with little oversight.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes, and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 5%, including international travel.
COMPENSATION
- The base pay for this position is $100,000.00 – $200,000.00. In specific locations, the pay range may vary from the range posted.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
INTRODUCTION
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
THE OPPORTUNITY
The Principal RA Specialist will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
This is an exciting opportunity with responsibilities for leading global regulatory submissions, which include but not limited to premarket submissions, pre-submissions and clinical trial applications, which include medical hardware and digital health technology solutions to address the spectrum of customer needs.
This individual has department level influence with experience in US/EU/global submissions and on-market changes and is generally recognized as an expert resource both within Abbott and externally. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
WHAT YOU’LL WORK ON
- Develop global regulatory strategies for product development and planning throughout the product lifecycle.
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
- Provide technical leadership and strategic input on complex issues and to business units.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Create project plans and timelines.
- Lead functional groups in the development of relevant data to complete a regulatory submission.
- Write and edit technical documents.
- Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
- Negotiate with regulatory authorities during the development and review process to ensure submission approval.
- Review and approve labeling to ensure compliance.
- Monitor emerging issues and identify solutions.
- Negotiate internally and externally with regulatory agencies.
- Evaluate regulatory risks of corporate policies.
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
- Ensure compliance with product post-marketing approval requirements.
- Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
- Actively contribute to the development and functioning of the crisis/issue management program.
- Analyze product-associated problems and develop proposals for solutions.
- Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications.
REQUIRED QUALIFICATIONS
- Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications).
- Experienced in regulatory submissions for In Vitro Diagnostic Devices and/or Medical Devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Device Regulation (2017/745) and/or the In Vitro Diagnostic Regulation (IVDR 2017/746).
PREFERRED QUALIFICATIONS
- 5 years’ experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus.
- Experience with either 510(k) applications, PMA supplements, US Device Regulations, or with EU and other International Medical Device Regulations and Submissions.
- Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical investigations, ICH guidelines.
- Experience with word processing, spreadsheet and presentation graphic software packages.
- Experience working in a broader enterprise/cross-division business unit model.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Ability to identify, solve problems, and work independently with little oversight.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes, and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 5%, including international travel.
COMPENSATION
- The base pay for this position is $100,000.00 – $200,000.00. In specific locations, the pay range may vary from the range posted.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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Entry Level Regulatory Affairs Analyst Jobs: Frequently Asked Questions
How do I get an entry level regulatory affairs analyst job?
Entry level regulatory affairs analyst roles typically look for a bachelor's degree in a life sciences, chemistry, engineering, or related field, plus familiarity with regulatory frameworks such as FDA submission processes or ISO standards. Internship experience in quality assurance, clinical research, or compliance gives candidates a clear edge. Highlighting coursework projects, any FDA or RAC certification study, and attention to detail in your application strengthens your profile at this stage.
Which companies hire entry level regulatory affairs analysts?
Companies hiring entry level regulatory affairs analysts right now include Oscar Health, Abbott, and Dentsply Sirona, based on current listings on Migrate Mate as of July 2026. Hiring at this level covers pharmaceutical manufacturers, medical device companies, biotech startups, and contract research organizations that bring on junior talent to support submission preparation and compliance documentation.
Are there remote entry level regulatory affairs analyst jobs?
Yes, though many roles at this level are on-site or hybrid given the hands-on compliance and documentation work involved. About 24% of entry level regulatory affairs analyst openings are remote or hybrid as of July 2026, so candidates open to in-office positions will find a broader pool of opportunities at the junior level.
Are these new grad regulatory affairs analyst jobs?
Yes, these listings include new grad, recent graduate, and junior regulatory affairs analyst roles. A posting is typically new-grad friendly when it welcomes zero to two years of experience, accepts internship or co-op work in lieu of full-time history, or invites candidates with a relevant degree and a portfolio of academic or project-based regulatory work. Searching for terms like 'new grad' or 'junior' alongside the role title surfaces the most entry-accessible openings.
Which industries hire the most entry level regulatory affairs analysts?
Entry Level regulatory affairs analyst roles concentrate in Biotechnology & Pharmaceuticals, Medical Devices, and Insurance, based on current listings on Migrate Mate as of July 2026. These sectors drive hiring at the junior level because they face ongoing regulatory submission requirements, product lifecycle filings, and quality compliance obligations that give new analysts structured, high-volume work from day one.