Senior Regulatory Affairs Specialist

Medtronic

Senior Regulatory Affairs Specialist ensuring compliance in medical device regulatory processes. Collaborating across departments to manage regulatory submissions and maintain product compliance with international standards.

Posted 4/23/2026full-timeColorado, Connecticut, Massachusetts • 🇺🇸 United StatesSenior💰 $92,000 - $138,000 per yearWebsite

About the role

Key responsibilities & impact

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 to support 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
Monitor regulatory procedures and changes

Requirements

What you’ll need

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
Knowledge of FDA and EU MDR requirements
Experience of working with all classification of product in the U.S and/or EU
Design Dossier and/or Technical Documentation experience
Technical Writing
International medical device regulatory submission/approval experience, to include FDA and EU
Product Labeling requirements and standards
May have practical knowledge of project management Systems Knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems

Benefits

Comp & perks

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
Incentive plans
401(k) plan plus 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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairs510(k) submissionstechnical writingDesign DossierTechnical Documentationproduct labelinginternational regulatory submissionFDA requirementsEU MDR requirementsproject management

Soft Skills

strategic guidancenegotiationcollaborationprioritizationcommunicationorganizational skillstime managementaudit participationcompliance reviewinformation sharing