Regulatory Affairs Manager Jobs for OPT Students
Regulatory Affairs Manager jobs on OPT require employers to sponsor work authorization before your OPT period ends. Most roles sit inside pharma, biotech, or medical device companies and expect a degree in life sciences, chemistry, or a related field. STEM OPT extension eligibility is common for this role.
See All Regulatory Affairs Manager JobsOverview
Showing 5 of 31+ Regulatory Affairs Manager jobs
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
See all 31+ Regulatory Affairs Manager jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Manager roles.
Get Access To All JobsINTRODUCTION
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.
THE OPPORTUNITY
This Regulatory Affairs Manager – APAC position will work on-site at 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 Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products to meet required legislation in the APAC region. You will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region.
WHAT YOU’LL WORK ON
- Managing a team of regulatory specialists
- Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture.
- Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on regulatory requirements in the APAC region for Diabetes care’s projects.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the APAC region.
- Provide strategic input and technical guidance on regulatory authority queries.
- Evaluate proposed design and manufacturing changes for regulatory impact and implement required regulatory actions.
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
- Ensure compliance with product post marketing approval requirements.
- Review product labeling and promotional materials to ensure compliance with relevant regulatory requirements.
- Provide regulatory support for internal and external audits.
REQUIRED QUALIFICATIONS
- Bachelor's Degree OR an equivalent combination of education and experience.
- 4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Strong verbal and written communications with ability to effectively communicate and present at multiple levels in the organization.
PREFERRED QUALIFICATIONS
- Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
- Masters in technical area or MBA; PhD in a technical area or law.
- 5+ years’ experience in regulatory affairs.
- Supervisory experience.
- Scientific writing experience.
- Working knowledge of ISO and EN standards, as well as country-specific standards in the APAC region.
- Strong working knowledge of regulatory requirements for the APAC region.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
COMPENSATION
- The base pay for this position is $114,000.00 – $228,000.00. 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.
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.
THE OPPORTUNITY
This Regulatory Affairs Manager – APAC position will work on-site at 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 Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products to meet required legislation in the APAC region. You will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region.
WHAT YOU’LL WORK ON
- Managing a team of regulatory specialists
- Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture.
- Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on regulatory requirements in the APAC region for Diabetes care’s projects.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the APAC region.
- Provide strategic input and technical guidance on regulatory authority queries.
- Evaluate proposed design and manufacturing changes for regulatory impact and implement required regulatory actions.
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
- Ensure compliance with product post marketing approval requirements.
- Review product labeling and promotional materials to ensure compliance with relevant regulatory requirements.
- Provide regulatory support for internal and external audits.
REQUIRED QUALIFICATIONS
- Bachelor's Degree OR an equivalent combination of education and experience.
- 4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Strong verbal and written communications with ability to effectively communicate and present at multiple levels in the organization.
PREFERRED QUALIFICATIONS
- Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
- Masters in technical area or MBA; PhD in a technical area or law.
- 5+ years’ experience in regulatory affairs.
- Supervisory experience.
- Scientific writing experience.
- Working knowledge of ISO and EN standards, as well as country-specific standards in the APAC region.
- Strong working knowledge of regulatory requirements for the APAC region.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
COMPENSATION
- The base pay for this position is $114,000.00 – $228,000.00. 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.
How to Get Visa Sponsorship as a Regulatory Affairs Manager
Focus on regulated industries with established immigration programs
Pharma, biotech, and medical device companies sponsor OPT workers far more consistently than other sectors. These industries have compliance-driven hiring structures and legal teams already familiar with work authorization timelines, making sponsorship conversations less friction-heavy.
Lead with your regulatory credentials in applications
RAC certification, FDA submission experience, or hands-on work with 510(k) or IND filings signals specialized expertise. Employers weigh sponsorship costs against candidate value, so concrete credentials make the business case for sponsoring your visa status stronger.
Time your applications around your OPT expiration window
Apply at least six months before OPT expires so employers have runway to file an H-1B petition or explore cap-exempt options. Hiring managers need time for internal approvals, and compressing that timeline often kills otherwise viable sponsorship conversations.
Understand the specialty occupation argument for your role
Regulatory Affairs Manager qualifies as a specialty occupation because it requires a specific life sciences or engineering degree. Being able to articulate that clearly to a hiring manager removes a common objection and shows you understand the visa process.
Ask about sponsorship policy during the first interview
Raise work authorization early rather than after an offer. Ask specifically whether the company has sponsored H-1B petitions for this role before. A prior sponsorship history in regulatory affairs is the strongest signal that sponsorship is genuinely available.
Regulatory Affairs Manager jobs are hiring across the US. Find yours.
Find Regulatory Affairs Manager JobsSee all 31+ Regulatory Affairs Manager jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Manager roles.
Get Access To All JobsFrequently Asked Questions
Does a Regulatory Affairs Manager role qualify for the STEM OPT extension?
It depends on your underlying degree. If your degree is in a STEM-designated field such as biochemistry, biomedical engineering, chemistry, or pharmaceutical sciences, you likely qualify for the 24-month STEM OPT extension. The extension is tied to your degree's CIP code, not your job title. Confirm your program qualifies through your DSO before accepting an offer that depends on the extended timeline.
What types of employers hire Regulatory Affairs Managers on OPT?
Pharmaceutical companies, biotechs, medical device manufacturers, and contract research organizations are the most active sponsors for this role. These employers operate in heavily regulated environments where regulatory affairs expertise is a core business function, not a peripheral one, making them more willing to invest in sponsorship. Browse Migrate Mate to filter specifically for employers that have sponsored OPT workers in this field.
Can I work as a Regulatory Affairs Manager on standard 12-month OPT without a STEM extension?
Yes. Standard OPT authorizes full-time employment in a role related to your degree field, and Regulatory Affairs Manager qualifies if your degree is in life sciences, chemistry, engineering, or a closely related discipline. The practical challenge is that 12 months is a short window for an employer to initiate H-1B sponsorship, so companies with experience sponsoring OPT workers are a better fit than those new to the process.
Does the Regulatory Affairs Manager role qualify as a specialty occupation for H-1B purposes?
Generally yes. The role requires specialized knowledge of regulatory frameworks such as FDA regulations, EU MDR, or ICH guidelines, and a specific bachelor's degree or higher in a related field is the standard entry requirement. USCIS has approved H-1B petitions for regulatory affairs roles consistently, though individual petition outcomes depend on how the employer defines the position in the Labor Condition Application.
What should I do if an employer says they don't sponsor visas for this role?
First, clarify whether they mean H-1B specifically or all work authorization. Some employers are unfamiliar with OPT, which doesn't require them to file a petition and has minimal administrative burden. If they still decline, prioritize employers with a documented sponsorship history. Focusing your search on verified sponsoring employers from the start saves significant time.
See which Regulatory Affairs Manager employers are hiring and sponsoring visas right now.
Search Regulatory Affairs Manager Jobs