Senior Export Compliance Specialist
Intel Corporation
Senior Regulatory Affairs Specialist
Medtronic
full-time
Posted on:
Location Type: Hybrid
Location: Santa Rosa • California, Minnesota • 🇺🇸 United States
Visit company websiteSalary
💰 $103,200 - $154,800 per year
Job Level
Senior
Tech Stack
Cyber SecuritySDLC
About the role
- Support Research and Development programs with pre-market regulatory strategy development for worldwide product registration with global regulatory agencies
- Provide advice on regulatory requirements and prepare worldwide submissions
- Negotiate approval of regulatory submissions
- Work in collaboration with Regulatory Affairs Team members and cross functional members
- Support US and international submissions, change management assessments, review and approval of advertising and promotional materials
- Provide ongoing support to product development teams for regulatory issues and questions
- Find, interpret and apply regulations and guidance appropriately
- Provide business and product information to enable development of strategies and requirements
- Participate in inspections/audits either performed internally or by other international regulatory bodies
Requirements
- Bachelor’s degree in a technical discipline
- 4+ years of medical device regulatory experience OR 2+ years of medical device regulatory experience with an advanced degree
- Experience working in regulated environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA, Notified Bodies, NMPA and PMDA etc.), and working with cross-functional project teams
- Master of Science Degree
- In depth experience with FDA requirements, guidance documents, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
- Experience working with cross functional PDP teams
- Direct Regulatory Affairs experience supporting programs throughout software development life cycle
- Direct experience authoring and successful approval of regulatory submissions for Class IIb /III/IV medical devices in the US, Japan, or EU (e.g., IDE, PMA, CTN, Shonin, Technical Documentation)
- Direct experience supporting successful software device development (SaMD, AI, Cybersecurity, IEC 62304/82304) and associated regulatory filings in the U.S., EU, and globally
- Experience with negotiations/interactions with regulatory agencies/health authorities
- Experience performing advertising and promotion reviews/approvals for medical devices
- Computer skills: MS Office, MS Project, Adobe Acrobat and Agile
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 (global well-being program)
- 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 (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategy developmentregulatory submissionsmedical device regulationISO 14971ISO 13485software development life cycleregulatory affairsauthoring regulatory submissionssoftware device developmentadvertising and promotion reviews
Soft skills
collaborationnegotiationinterpretation of regulationsproblem-solvingcommunication
Certifications
Bachelor’s degreeMaster of Science Degree
