Manager, Regulatory Operations
Tempus AI
Google Cloud Platform
Principal Regulatory Affairs Specialist
Medtronic
full-time
Posted on:
Location Type: Hybrid
Location: Mounds View • California, Minnesota • 🇺🇸 United States
Visit company websiteSalary
💰 $118,400 - $177,600 per year
Job Level
Lead
Tech Stack
Cyber SecurityPMPSDLC
About the role
- Supports Research and Development programs with early phase pre-market regulatory strategy development with a view through the full product lifecycle
- Brings hands-on expertise in regulatory software development strategies (SaMD, AI, Machine Learning, Cybersecurity, etc.)
- Collaborates with Regulatory Affairs Team members, cross functional members, and International Regulatory Affairs staff
- Engages in compliance activities (preparation and execution)
- Acts as a mentor to colleagues and effectively manages an extended team
- Partners in problem resolution and keeps objectives moving in line with program estimates
- Represents the Regulatory Affairs function on product development teams
- Leads preparations of documentation for regulatory submissions
Requirements
- Bachelor’s degree in a technical discipline
- Minimum of 7 years of direct Regulatory Affairs experience within the medical device or other regulated industry
- Or advanced degree with a minimum of 5 years of Regulatory Affairs experience
- Medical device industry experience with Class I/II/III/IV software products
- Direct Regulatory Affairs experience supporting programs throughout software development life cycle (Nice To Have)
- In depth experience supporting successful software device development (SaMD, AI, Cybersecurity, IEC 62304/82304) and associated regulatory filings in the U.S., EU, and globally (Nice To Have)
- Experience performing advertising and promotion reviews/approvals for medical devices (Nice To Have)
- Experience engaging regulatory bodies (Nice To Have)
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences) (Nice To Have)
- Analytical, process and data visualization experience (Nice To Have)
- Working knowledge of Project Management methodologies and tools; PMP certification is an asset (Nice To Have)
- Demonstrated strong business acumen and planning (Nice To Have)
- Strong interpersonal, quantitative analysis, and problem-solving skills (Nice To Have)
- High degree of initiative and influence management skills (Nice To Have)
- Experience working in a hybrid team environment in supporting cross-functional teams remotely (Nice To Have)
- Results oriented (Nice To Have)
- Ability to drive to completion in adherence to aggressive project schedules (Nice To Have)
- Ability to manage multiple projects and proficiency with Microsoft Office and software tools (Nice To Have)
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 software developmentSaMDAIMachine LearningCybersecurityIEC 62304IEC 82304regulatory submissionssoftware development life cycle
Soft skills
mentoringproblem resolutionbusiness acumenplanninginterpersonal skillsquantitative analysisproblem-solvinginitiativeinfluence managementresults oriented
Certifications
PMP certification
