OPT Regulatory Affairs Manager Jobs
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.
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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
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
ROLE AND RESPONSIBILITIES
This Regulatory Affairs Manager position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division. The candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. This new team member has department/group/site level influence and is generally recognized as an expert resource and mentor within the department.
- Develop new regulatory policies, processes and SOPs and train key staff on them. Evaluate regulatory risks of division policies, processes, procedures.
- Provide regulatory input to product lifecycle planning. Provide strategic input and technical guidance on regulatory requirements to development teams
- Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectives
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
- Support pre and post approval clinical strategy and submission activities
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
- Assess the acceptability of development, quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
- Ensure compliance with US and global product post marketing approval requirements
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
- Execute and manage technical and scientific regulatory activities. Must function independently as a decisionmaker on regulatory issues and must assure that deadlines are met
- Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements.
- Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units
- Provide leadership and guidance towards achieving department objectives and act as a mentor to less-experienced staff
- May supervise exempt or non-exempt employees
- May lead a cross-functional or cross-divisional project team
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures
BASIC QUALIFICATIONS
- Bachelor's Degree in a related field OR an equivalent combination of education and work experience
- Minimum 4 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. Note: Higher education may compensate for years of experience.
- Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
- Domestic and international regulatory guidelines, policies and regulations.
- Lead functional groups in the development of relevant data to complete a regulatory submission.
PREFERRED QUALIFICATIONS
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
- Master’s or Ph.D. in a technical area
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions
- Experience with Class II and Class III medical devices
- Ability to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
- Experience with post-approval manufacturing and design changes
- Ability to work effectively on cross-functional teams
- Strong attention to detail
- Experience with organizing and tracking complex information. Able to juggle multiple and competing priorities
- Experience with exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business
- Uses in-depth knowledge of business functions and cross group dependencies/relationships
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.
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.
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
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
ROLE AND RESPONSIBILITIES
This Regulatory Affairs Manager position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division. The candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. This new team member has department/group/site level influence and is generally recognized as an expert resource and mentor within the department.
- Develop new regulatory policies, processes and SOPs and train key staff on them. Evaluate regulatory risks of division policies, processes, procedures.
- Provide regulatory input to product lifecycle planning. Provide strategic input and technical guidance on regulatory requirements to development teams
- Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectives
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
- Support pre and post approval clinical strategy and submission activities
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
- Assess the acceptability of development, quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
- Ensure compliance with US and global product post marketing approval requirements
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
- Execute and manage technical and scientific regulatory activities. Must function independently as a decisionmaker on regulatory issues and must assure that deadlines are met
- Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements.
- Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units
- Provide leadership and guidance towards achieving department objectives and act as a mentor to less-experienced staff
- May supervise exempt or non-exempt employees
- May lead a cross-functional or cross-divisional project team
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures
BASIC QUALIFICATIONS
- Bachelor's Degree in a related field OR an equivalent combination of education and work experience
- Minimum 4 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. Note: Higher education may compensate for years of experience.
- Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
- Domestic and international regulatory guidelines, policies and regulations.
- Lead functional groups in the development of relevant data to complete a regulatory submission.
PREFERRED QUALIFICATIONS
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
- Master’s or Ph.D. in a technical area
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions
- Experience with Class II and Class III medical devices
- Ability to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
- Experience with post-approval manufacturing and design changes
- Ability to work effectively on cross-functional teams
- Strong attention to detail
- Experience with organizing and tracking complex information. Able to juggle multiple and competing priorities
- Experience with exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business
- Uses in-depth knowledge of business functions and cross group dependencies/relationships
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.
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.
See all OPT Regulatory Affairs Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Regulatory Affairs Manager Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Regulatory Affairs Manager
Target STEM-designated programs first
Regulatory Affairs Manager roles frequently fall under STEM OPT extension eligibility. Confirm your degree program's CIP code qualifies before applying, as this gives you up to 24 additional months of work authorization to secure H-1B visa sponsorship.
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 OPT: Frequently 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.