Regulatory Affairs Specialist
About The Position
The Regulatory Affairs Specialist supports international regulatory strategies and submission activities across global markets. The role assists with new product registrations, renewals, amendments, and country-specific regulatory requirements to help ensure compliance and maintain market access. The specialist works with regional regulatory colleagues and cross-functional teams, including Quality, Clinical, Manufacturing, and Marketing, to support submission readiness, coordinate documentation, and contribute to timely execution. This is an on-site position based in North Haven, Connecticut; Lafayette, Colorado; Mansfield, Massachusetts; or Mounds View, Minnesota. The role supports global submissions across Asia Pacific, the Middle East and Africa, Latin America, Canada, and EMEA. It also helps track timelines, identify submission risks, respond to health authority questions, and support lifecycle management of regulated products.
Requirements
- Bachelor’s degree required.
- At least 2 years of relevant experience, or an advanced degree and at least 0 years of relevant experience.
- For baccalaureate degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice To Haves
- Experience with U.S. FDA and international regulatory requirements for medical devices.
- Familiarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standards.
- Experience supporting regulatory submissions, audits, or inspections.
- Strong written and verbal communication skills.
- Strong organizational skills and ability to manage multiple priorities.
- Experience collaborating in a cross-functional, fast-paced environment.
- Familiarity with medical device product development or lifecycle management.
- RAC certification or progress toward certification.
- Experience working with Notified Bodies or global regulatory agencies.
Responsibilities
- Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections.
- Compile materials for global submissions, license renewals, amendments, and responses to health authority inquiries.
- Assess regulatory requirements and help recommend submission strategies based on business needs, risk, and timelines.
- Support critical, complex, and time-sensitive registrations while balancing compliance and operational priorities.
- Review regulatory, technical, quality, labeling, and product documentation for completeness, accuracy, and consistency.
- Manage multiple projects while tracking deadlines, action items, and submission status.
- Identify regulatory risks, gaps, and delays early and escalate issues as needed.
- Communicate regulatory requirements to internal and external stakeholders.
- Stay current with regulatory procedures, guidelines, and changes in global requirements, and communicate relevant updates to internal teams.
- Apply judgment to support regulatory activities, collaborate with stakeholders, and assist team members.
- Identify opportunities to streamline submission processes, trackers, and cross-functional ways of working.
Benefits
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).
- For regular employees working 20 or more hours per week: health, dental, and vision insurance; Health Savings Account; Healthcare Flexible Spending Account; life insurance; long-term disability leave; dependent daycare spending account; tuition assistance/reimbursement; and the Simple Steps global well-being program.
- For all regular employees: incentive plans; 401(k) plan with employer contribution and match; short-term disability; paid time off; paid holidays; Employee Stock Purchase Plan; Employee Assistance Program; Non-qualified Retirement Plan Supplement (subject to IRS earning minimums); and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
