Senior Regulatory Affairs Specialist Jobs
Senior Regulatory Affairs Specialist jobs are open across pharmaceuticals, medical devices, biotechnology, and consumer products, from mid-level to director-adjacent roles, with specializations in FDA submissions, global regulatory strategy, and labeling compliance. Find a role that fits from the openings below and apply directly.
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Showing 5 of 26+ Senior Regulatory Affairs Specialist 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.
ABOUT ABBOTT
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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.
ABOUT LINGO
Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.
THE OPPORTUNITY
Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.
As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. This is an exciting on-site opportunity at Lingo in Alameda, CA.
WHAT YOU’LL WORK ON
- Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
- Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.
- Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
- Assist with promotional content development and review for compliance before distribution.
- Lead Regulatory Affairs Ad & Promo SOP development and review.
- Prepares robust regulatory applications/submissions to regulatory authorities.
- Assist in SOP development and review in support of "next-gen" product offerings.
- Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Ensure compliance with product post marketing requirements.
- Review product labeling to ensure compliance with relevant regulatory requirements.
- Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Influences middle management on technical or business solutions.
REQUIRED QUALIFICATIONS:
- Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
- Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.
PREFERRED QUALIFICATIONS:
- Advanced degree in Engineering, Sciences, or related discipline.
- Previous experience with 510(k)/PMA submissions or class I / II exempt software devices.
- Experience with software medical devices.
- 4-6 years’ experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area.
- Ability to work effectively on cross-functional teams.
- Must be able to juggle multiple and competing priorities.
- Ability to identify and solve problems and work independently with little oversight.
- Strong written, verbal, presentation, and organizational skills.
- Working knowledge of FDA QSR.
- Has a sound knowledge of a variety of alternatives and their impact on the business.
COMPENSATION
- The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.
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.
ABOUT ABBOTT
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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.
ABOUT LINGO
Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.
THE OPPORTUNITY
Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.
As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. This is an exciting on-site opportunity at Lingo in Alameda, CA.
WHAT YOU’LL WORK ON
- Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
- Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.
- Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
- Assist with promotional content development and review for compliance before distribution.
- Lead Regulatory Affairs Ad & Promo SOP development and review.
- Prepares robust regulatory applications/submissions to regulatory authorities.
- Assist in SOP development and review in support of "next-gen" product offerings.
- Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Ensure compliance with product post marketing requirements.
- Review product labeling to ensure compliance with relevant regulatory requirements.
- Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Influences middle management on technical or business solutions.
REQUIRED QUALIFICATIONS:
- Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
- Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.
PREFERRED QUALIFICATIONS:
- Advanced degree in Engineering, Sciences, or related discipline.
- Previous experience with 510(k)/PMA submissions or class I / II exempt software devices.
- Experience with software medical devices.
- 4-6 years’ experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area.
- Ability to work effectively on cross-functional teams.
- Must be able to juggle multiple and competing priorities.
- Ability to identify and solve problems and work independently with little oversight.
- Strong written, verbal, presentation, and organizational skills.
- Working knowledge of FDA QSR.
- Has a sound knowledge of a variety of alternatives and their impact on the business.
COMPENSATION
- The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.
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.
See All Senior Regulatory Affairs Specialist Jobs
Jump back to the full list of openings and apply to any senior regulatory affairs specialist role that fits.
Find JobsSenior Regulatory Affairs Specialist Job Market
A snapshot from current openings nationwide, updated as new roles post.
Who's Hiring
- Insulet Corporation5
- Abbott4
- Evalve2
- Globus Medical2
- Melaleuca2
Top Industries Hiring
- Medical Devices13
- Biotechnology & Pharmaceuticals12
- Healthcare & Medical Services8
- Chemicals & Materials1
- Consumer Goods1
What Employers Look For
The qualifications that appear most often in senior regulatory affairs specialist jobs.
- Bachelor's degree in life sciences, chemistry, engineering, or a related field required
- Five or more years of regulatory affairs experience in pharmaceuticals, medical devices, or biotechnology
- Direct experience preparing and submitting FDA regulatory filings such as 510(k)s, NDAs, or BLAs
- Proficiency with eCTD publishing and regulatory information management systems such as Veeva Vault
- Regulatory Affairs Certification (RAC) from RAPS preferred or required for senior-level roles
- Strong working knowledge of FDA regulations, ICH guidelines, and applicable CFR sections
Tips for Your Senior Regulatory Affairs Specialist Job Search
Tailor your resume to submission types
Hiring managers scan for specific submission experience, whether that's 510(k)s, PMAs, NDAs, or BLAs. List each type you've led or contributed to by name so your resume clears keyword filters and signals hands-on regulatory depth immediately.
Highlight your regulatory database proficiency
Many postings require experience with Veeva Vault, RIMS, or eCTD publishing tools. Name each system you've used and describe the context, such as managing submissions or maintaining registration records, so recruiters don't have to guess.
Apply early to roles that fit
Migrate Mate lists senior regulatory affairs specialist openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Match your cover letter to the product stage
Regulatory work at a pre-market startup differs sharply from post-market compliance at an established manufacturer. Reference whether you prefer early-stage submissions or lifecycle management, and connect that preference directly to where the company's product sits.
Prepare case studies around agency interactions
Interview panels often ask how you handled an FDA deficiency letter, responded to a clinical hold, or negotiated label language. Walk through one real example with a clear problem, your specific action, and the outcome, without relying on vague teamwork language.
Negotiate based on scope, not just title
Senior regulatory affairs specialist roles vary widely in authority over strategy versus execution. Before accepting an offer, confirm whether you own submissions end-to-end or support them, since that scope difference affects both your daily work and your next career move.
Senior Regulatory Affairs Specialist Jobs: Frequently Asked Questions
Which companies are hiring the most senior regulatory affairs specialists?
The companies hiring the most senior regulatory affairs specialists right now include Insulet Corporation, Abbott, and Evalve, with the largest share of openings in California, Pennsylvania, and Idaho, based on current listings on Migrate Mate as of June 2026. Demand is consistently strongest at mid-to-large pharmaceutical and medical device manufacturers with active product pipelines.
How many senior regulatory affairs specialist jobs are remote?
About 31% of senior regulatory affairs specialist openings are fully remote or hybrid as of June 2026, reflecting a shift toward flexible arrangements across the life sciences sector. Roles focused on regulatory strategy, labeling review, and post-market surveillance tend to be more remote-compatible than positions requiring on-site lab access or direct manufacturing oversight.
How do you become a senior regulatory affairs specialist?
You typically start with a bachelor's degree in a life science, pharmacy, or engineering field, then move into an entry-level regulatory affairs role such as regulatory coordinator or associate specialist. From there you build hands-on submission experience across one or more product types, pursue your RAC credential through RAPS to demonstrate regulatory fluency, and take on increasing responsibility for leading submissions and advising cross-functional teams before stepping into a senior title.
Can you get hired as a senior regulatory affairs specialist without direct regulatory experience?
It's difficult to land a senior role without some regulatory foundation, but candidates from adjacent fields like clinical affairs, quality assurance, or medical writing do make the transition. The most effective approach is to identify where your existing work touched regulatory processes, such as supporting audits, reviewing labeling, or contributing to submissions, then frame that experience explicitly rather than expecting hiring managers to connect the dots on your behalf.
What does the senior regulatory affairs specialist interview process look like?
Most processes begin with a recruiter screen focused on your submission history and regulatory systems experience, followed by a panel interview with regulatory leadership and cross-functional partners from clinical, quality, or legal. You'll likely be asked to walk through a complex submission or an agency interaction you managed. Some employers add a written exercise where you review a mock deficiency letter or draft a regulatory strategy summary to assess your technical judgment.
Where can I find and apply to senior regulatory affairs specialist jobs?
You can find and apply to senior regulatory affairs specialist jobs on Migrate Mate, which lists current openings from across the United States. Search the available roles, find the ones that match your background and target product area, and apply directly to each listing that fits.
See All Senior Regulatory Affairs Specialist Jobs
Jump back to the full list of openings and apply to any senior regulatory affairs specialist role that fits.
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