Senior Manager, Learning & Technology Operations, Compliance
Cars Commerce
Senior Regulatory Affairs Specialist – Clinical
Medtronic
full-time
Posted on:
Location Type: Remote
Location: Remote • California, Minnesota, Texas • 🇺🇸 United States
Visit company websiteSalary
💰 $92,000 - $138,000 per year
Job Level
Senior
About the role
- Develop and refine least burdensome clinical regulatory strategies to support innovations in the Diabetes business with stakeholders across the business
- Maintain proficiency of worldwide regulatory intelligence, including competitor filings, as part of developing innovative clinical regulatory strategies
- Manage projects assigned to support business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products that require clinical evidence
- Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies
- Prepare FDA, European, and rest of world clinical submissions for next-generation diabetes products and product changes that require clinical evidence
- Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed
- Responsible for the preparation of the clinical portion of submission packages for commercialization
- Assisting with license maintenance, including annual reports, renewals, design change notifications, and QMS audits
- Follow all work/quality procedures to ensure quality system compliance and high-quality work
- Interact directly with FDA, Notified Bodies, and international regulatory agencies on most projects/products at the reviewer level
Requirements
- Bachelor's degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review
- Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review
- Direct experience in the medical device industry, particularly with Class III/II medical devices for both FDA and EU Regulatory Submission
- Proven experience preparing and submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies
- In-depth understanding of FDA requirements, FDA and MDCG guidance documents, EU MDR, ISO 14971, ISO 13485, Good Clinical Practice, ICH guidelines, and other global regulatory requirements and quality standards
- Proficiency in MS Office, MS Project, and Adobe Acrobat
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
- Short-term disability
- 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 affairsclinical regulatory strategiesmedical device submissionsregulatory filingsFDA requirementsEU MDRISO 14971ISO 13485Good Clinical PracticeICH guidelines
Soft skills
collaborationproject managementproblem-solvingcommunicationinterpersonal skillsorganizational skillsattention to detailquality assurance
