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
About the role
- Act as a team member on development projects to provide regulatory guidance and develop global regulatory strategies and timelines for key markets.
- Author and prepare regulatory submissions for new products and their product changes as required to ensure timely approval for market release.
- Review significant regulatory issues with manager, as necessary, and resolve submission issues with Medtronic cross functional partners.
- Prepare regulatory strategies/plans taking inputs and incorporating worldwide compliance requirements.
- Provide on-going support to product development teams for regulatory issues and questions.
- Find, interpret and apply regulations and guidance appropriately for situations.
- Provide regulatory support for currently marketed products as necessary.
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
- Experience working with cross-functional project teams
- Master of Science Degree (Nice to Have)
- In depth experience with FDA requirements, guidance documents, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
- Direct experience authoring and successful approval of regulatory submissions for Class IIb /III/IV medical devices in the US, Japan, or EU
- Direct experience supporting successful software device development and associated regulatory filings
- 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
- Incentive plans
- 401(k) plan plus employer contribution and match
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsregulatory strategiesFDA requirementsMedical Device RegulationISO 14971ISO 13485regulatory experiencesoftware device developmentadvertising and promotion reviewsquality standards
Soft skills
team collaborationproblem-solvingcommunicationcross-functional teamworkregulatory guidance
Certifications
Bachelor’s degreeMaster of Science Degree
