Senior Level Regulatory Specialist Jobs
Senior level regulatory specialist jobs put experienced professionals in charge of compliance strategy, regulatory submissions, and the cross-functional teams or projects that carry them to completion. Roles concentrate across Medical Devices, Biotechnology & Pharmaceuticals, and Manufacturing, with a mix of on-site, remote, and hybrid settings, and employers like Pace Analytical Services, Stripe, and ImmunityBio hiring at this level now.
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About Elevaris Medical Devices
Tired of working at a "good" job?
At Elevaris, our goal is not to be good, it's to be extraordinary.
Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field.
Elevaris Medical Devices is leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.
Please note this position is onsite in Wilmington Mass.
ROLE PURPOSE
- The Principal Regulatory Affairs Specialist serves as the highest-level individual contributor within Regulatory Affairs and is responsible for developing and executing global regulatory strategies that support product development, registration, commercialization, market expansion, and lifecycle management of Elevaris products. This role provides advanced regulatory leadership for complex projects, serves as a key subject matter expert on U.S., EU, and international regulatory requirements, and partners closely with cross-functional teams to ensure regulatory objectives align with business priorities.
- The position independently leads complex submissions, drives regulatory strategy, assesses regulatory risk, supports agency interactions, and mentors Regulatory Affairs team members while ensuring ongoing compliance with applicable global regulations.
KEY RESPONSIBILITIES & ACCOUNTABILITIES
- Develop and lead regulatory strategies supporting new product development, product modifications, market expansion, and lifecycle management
- Serve as the primary regulatory affairs representative on cross-functional product development teams.
- Provide regulatory guidance and risk assessments related to design, manufacturing, supplier, and labeling changes
- Lead preparation and submission of 510(k)s, PMAs, IDEs, international registrations, renewals, and regulatory assessments
- Coordinate responses to regulatory agency requests and represent regulatory perspectives with FDA, Notified Bodies, and global authorities
- Review and approve engineering changes, labeling, IFUs, promotional materials, and development documentation
- Develop and maintain Technical Files, Design History Files, and regulatory dossiers
- Monitor emerging regulations and assess business impact
- Provide technical mentorship and leadership to Regulatory Affairs team members
DECISION RIGHTS & KEY RELATIONSHIPS
- Independently make regulatory decisions within established frameworks
- Recommend regulatory strategies and risk mitigation approaches for complex projects
- Collaborate with Quality, R&D, Clinical Affairs, Manufacturing, Supply Chain, Marketing, and Commercial teams
WHAT SUCCESS LOOKS LIKE
- Regulatory submissions are completed accurately and on schedule
- Products remain compliant with global regulations
- Regulatory risks are proactively identified and mitigated
- Regulatory strategies support business growth and innovation
CAPABILITIES & QUALIFICATIONS
Minimum Requirements:
- Bachelor’s degree in a scientific discipline required; advanced degree preferred
- 8+ years of progressive Regulatory Affairs experience in medical devices
- Experience leading FDA submissions including 510(k)s
- Advanced knowledge of FDA, EU MDR, ISO 13485, and global regulatory requirements
- Strong project leadership, communication, and risk assessment skills
Preferred Qualifications:
- RAC certification
HOW WE WORK
At Elevaris, what we accomplish matters — and so does how we accomplish it. Every employee is expected to demonstrate our Values of Integrity, Invested, Inclusion and Ingenuity through their everyday decisions, behaviors and interactions.
WORK ENVIRONMENT & PHYSICAL REQUIREMENTS
The physical demands described here are representative of those required to successfully perform the essential functions of this role. Reasonable accommodation may be made in accordance with applicable local laws. Contact your manager or HR to understand the work conditions and physical requirements that may be specific to your role.
10-15% domestic and international travel as required- Regular use of computer and communication tools
- Ability to work independently and/or in a team environment
- Additional requirements may vary by role and location
GLOBAL COMPLIANCE & EQUAL OPPORTUNITY
Elevaris is committed to providing equal employment opportunities in all locations where we operate. We do not discriminate on the basis of any characteristic protected by applicable local laws.
An Equal Opportunity Employer/Contractor: Elevaris believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.
The pay range for this role is:
123,000 - 150,000 USD per year(Wilmington MA)
About Elevaris Medical Devices
Tired of working at a "good" job?
At Elevaris, our goal is not to be good, it's to be extraordinary.
Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field.
Elevaris Medical Devices is leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.
Please note this position is onsite in Wilmington Mass.
ROLE PURPOSE
- The Principal Regulatory Affairs Specialist serves as the highest-level individual contributor within Regulatory Affairs and is responsible for developing and executing global regulatory strategies that support product development, registration, commercialization, market expansion, and lifecycle management of Elevaris products. This role provides advanced regulatory leadership for complex projects, serves as a key subject matter expert on U.S., EU, and international regulatory requirements, and partners closely with cross-functional teams to ensure regulatory objectives align with business priorities.
- The position independently leads complex submissions, drives regulatory strategy, assesses regulatory risk, supports agency interactions, and mentors Regulatory Affairs team members while ensuring ongoing compliance with applicable global regulations.
KEY RESPONSIBILITIES & ACCOUNTABILITIES
- Develop and lead regulatory strategies supporting new product development, product modifications, market expansion, and lifecycle management
- Serve as the primary regulatory affairs representative on cross-functional product development teams.
- Provide regulatory guidance and risk assessments related to design, manufacturing, supplier, and labeling changes
- Lead preparation and submission of 510(k)s, PMAs, IDEs, international registrations, renewals, and regulatory assessments
- Coordinate responses to regulatory agency requests and represent regulatory perspectives with FDA, Notified Bodies, and global authorities
- Review and approve engineering changes, labeling, IFUs, promotional materials, and development documentation
- Develop and maintain Technical Files, Design History Files, and regulatory dossiers
- Monitor emerging regulations and assess business impact
- Provide technical mentorship and leadership to Regulatory Affairs team members
DECISION RIGHTS & KEY RELATIONSHIPS
- Independently make regulatory decisions within established frameworks
- Recommend regulatory strategies and risk mitigation approaches for complex projects
- Collaborate with Quality, R&D, Clinical Affairs, Manufacturing, Supply Chain, Marketing, and Commercial teams
WHAT SUCCESS LOOKS LIKE
- Regulatory submissions are completed accurately and on schedule
- Products remain compliant with global regulations
- Regulatory risks are proactively identified and mitigated
- Regulatory strategies support business growth and innovation
CAPABILITIES & QUALIFICATIONS
Minimum Requirements:
- Bachelor’s degree in a scientific discipline required; advanced degree preferred
- 8+ years of progressive Regulatory Affairs experience in medical devices
- Experience leading FDA submissions including 510(k)s
- Advanced knowledge of FDA, EU MDR, ISO 13485, and global regulatory requirements
- Strong project leadership, communication, and risk assessment skills
Preferred Qualifications:
- RAC certification
HOW WE WORK
At Elevaris, what we accomplish matters — and so does how we accomplish it. Every employee is expected to demonstrate our Values of Integrity, Invested, Inclusion and Ingenuity through their everyday decisions, behaviors and interactions.
WORK ENVIRONMENT & PHYSICAL REQUIREMENTS
The physical demands described here are representative of those required to successfully perform the essential functions of this role. Reasonable accommodation may be made in accordance with applicable local laws. Contact your manager or HR to understand the work conditions and physical requirements that may be specific to your role.
10-15% domestic and international travel as required- Regular use of computer and communication tools
- Ability to work independently and/or in a team environment
- Additional requirements may vary by role and location
GLOBAL COMPLIANCE & EQUAL OPPORTUNITY
Elevaris is committed to providing equal employment opportunities in all locations where we operate. We do not discriminate on the basis of any characteristic protected by applicable local laws.
An Equal Opportunity Employer/Contractor: Elevaris believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.
The pay range for this role is:
123,000 - 150,000 USD per year(Wilmington MA)
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Who's Hiring
Top Industries Hiring
- Medical Devices
- Biotechnology & Pharmaceuticals
- Manufacturing
- Banking & Financial Services
- Consulting & Professional Services
Senior Level Regulatory Specialist Jobs: Frequently Asked Questions
How do I get a senior level regulatory specialist job?
Employers at this level look for professionals who have led regulatory submissions, managed agency relationships, and guided others through complex compliance processes. A strong candidate brings demonstrated ownership of outcomes, not just execution of tasks. Specialized credentials, a history of cross-functional leadership, and the ability to interpret and apply evolving regulatory frameworks independently all sharpen your competitiveness at this stage.
Which companies hire senior level regulatory specialists?
Companies hiring senior level regulatory specialists right now include Pace Analytical Services, Stripe, and ImmunityBio, based on current listings on Migrate Mate as of November 2026. At this level, hiring tends to come from regulated industries with large compliance functions, including established corporations, government contractors, and organizations managing product approval or licensing pipelines.
Are there remote senior level regulatory specialist jobs?
Yes, though availability varies by industry and employer. About 67% of senior level regulatory specialist openings are remote or hybrid as of November 2026, reflecting broad adoption of flexible work in compliance-heavy fields. Roles involving on-site audits, lab oversight, or government facility access are more likely to require in-person presence.
What makes a regulatory specialist role senior level?
Senior level regulatory specialists own the strategy behind compliance programs, not just the execution. They interpret complex or shifting regulatory requirements, lead submissions or audits independently, and serve as the internal authority others rely on for guidance. Mentoring junior staff, managing agency relationships, and driving regulatory decisions that affect product timelines or business risk are defining expectations at this stage.
Which industries hire the most senior level regulatory specialists?
Senior Level regulatory specialist roles concentrate in Medical Devices, Biotechnology & Pharmaceuticals, and Manufacturing, based on current listings on Migrate Mate as of November 2026. These sectors drive demand because they operate under strict federal and state oversight, require ongoing submissions and approvals, and depend on experienced specialists to maintain compliance across complex, high-stakes product or operational environments.