Sr Regulatory Affairs Spec
Medtronic, North Haven, CT, United States
We anticipate the application window for this opening will close on 7 May 2026.
A Day in the Life
The Senior Regulatory Affairs Specialist (Sr. RAS) collaborates across departments to plan and execute regulatory activities for Medtronic’s Basic Energy and Access and Instrument product portfolio. Responsibilities include preparing and submitting regulatory documents such as 510(k) applications and CE technical files, conducting regulatory change assessments, and supporting EU Medical Device Regulation (MDR) implementation. The role translates regulatory requirements into actionable project or product requirements and works closely with multiple stakeholders to ensure accurate, on‑schedule regulatory deliveries.
Responsibilities
Provide strategic and technical regulatory guidance to support design and manufacturing sustaining, covering both domestic and international requirements.
Prepare 510(k) submissions/letter to file, change notices and updates to technical documents for US and EU markets.
Interact and negotiate with regulatory authorities during product development and review processes.
Share business and product information with international regulatory teams to inform strategy and communicate requirements to the business team.
Manage multiple projects, prioritize daily tasks, and ensure project deadlines are met.
Collaborate with engineering, quality, clinical, marketing, and other departments to fulfill regulatory responsibilities.
Review and approve promotional and advertising materials for compliance.
Stay up to date on domestic and international regulatory requirements, guidelines, and standards.
Participate in internal and external audits as required.
Maintain regulatory documentation to ensure compliance.
Coordinate and prepare document packages for regulatory submissions, audits, and inspections.
Monitor regulatory procedures and changes.
Interact directly with regulatory agencies on defined matters as needed.
Contribute to continuous improvement initiatives and process optimization within RA.
Perform additional duties as assigned.
Must Have: Minimum Requirements
Bachelor’s degree with 4+ years of regulatory affairs experience in the medical device, biotech, or pharmaceutical industry OR a master’s degree with 2+ years of regulatory affairs experience in the same industries.
Nice to Have
Knowledge of FDA and EU MDR requirements.
Experience working with all classifications of products in the U.S. and/or EU.
Design dossier and/or technical documentation experience.
Technical writing skills.
International medical device regulatory submission/approval experience, including FDA and EU MDR.
Product labeling requirements and standards.
Practical knowledge of project management.
Systems knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems.
Physical Job Requirements
The role requires independent mobility and routine use of a computer. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
U.S. Work Authorization & Sponsorship
Roles below the Principal level require applicants to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Benefits & Compensation
Salary range (USD): $92,000 – $138,000.
Eligible for the Medtronic Incentive Plan (short‑term incentive).
Benefits: 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; Simple Steps (well‑being program).
Retirement and other incentives: 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; Capital Accumulation Plan (for certain levels).
Equal Employment Opportunity
Medtronic provides equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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A Day in the Life
The Senior Regulatory Affairs Specialist (Sr. RAS) collaborates across departments to plan and execute regulatory activities for Medtronic’s Basic Energy and Access and Instrument product portfolio. Responsibilities include preparing and submitting regulatory documents such as 510(k) applications and CE technical files, conducting regulatory change assessments, and supporting EU Medical Device Regulation (MDR) implementation. The role translates regulatory requirements into actionable project or product requirements and works closely with multiple stakeholders to ensure accurate, on‑schedule regulatory deliveries.
Responsibilities
Provide strategic and technical regulatory guidance to support design and manufacturing sustaining, covering both domestic and international requirements.
Prepare 510(k) submissions/letter to file, change notices and updates to technical documents for US and EU markets.
Interact and negotiate with regulatory authorities during product development and review processes.
Share business and product information with international regulatory teams to inform strategy and communicate requirements to the business team.
Manage multiple projects, prioritize daily tasks, and ensure project deadlines are met.
Collaborate with engineering, quality, clinical, marketing, and other departments to fulfill regulatory responsibilities.
Review and approve promotional and advertising materials for compliance.
Stay up to date on domestic and international regulatory requirements, guidelines, and standards.
Participate in internal and external audits as required.
Maintain regulatory documentation to ensure compliance.
Coordinate and prepare document packages for regulatory submissions, audits, and inspections.
Monitor regulatory procedures and changes.
Interact directly with regulatory agencies on defined matters as needed.
Contribute to continuous improvement initiatives and process optimization within RA.
Perform additional duties as assigned.
Must Have: Minimum Requirements
Bachelor’s degree with 4+ years of regulatory affairs experience in the medical device, biotech, or pharmaceutical industry OR a master’s degree with 2+ years of regulatory affairs experience in the same industries.
Nice to Have
Knowledge of FDA and EU MDR requirements.
Experience working with all classifications of products in the U.S. and/or EU.
Design dossier and/or technical documentation experience.
Technical writing skills.
International medical device regulatory submission/approval experience, including FDA and EU MDR.
Product labeling requirements and standards.
Practical knowledge of project management.
Systems knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems.
Physical Job Requirements
The role requires independent mobility and routine use of a computer. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
U.S. Work Authorization & Sponsorship
Roles below the Principal level require applicants to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Benefits & Compensation
Salary range (USD): $92,000 – $138,000.
Eligible for the Medtronic Incentive Plan (short‑term incentive).
Benefits: 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; Simple Steps (well‑being program).
Retirement and other incentives: 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; Capital Accumulation Plan (for certain levels).
Equal Employment Opportunity
Medtronic provides equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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