Medtronic

Senior Regulatory Affairs Specialist – Structural Heart

Medtronic

full-time

Posted on:

Location Type: Hybrid

Location: Mounds View • California, Minnesota • 🇺🇸 United States

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Salary

💰 $103,200 - $154,800 per year

Job Level

Senior

About the role

  • Team with operating unit Regulatory Affairs Specialists and international regulatory staff to develop and execute regulatory strategies for new and existing products, ensuring alignment with business objectives and regulatory requirements.
  • Collaborate with R&D, Quality, Clinical, and Marketing teams to ensure regulatory compliance throughout the product development process and to resolve potential regulatory issues and questions from regulatory agencies.
  • Prepare regulatory documentation for new products, product changes, audits, as required, to ensure timely approvals and compliance for clinical studies and market release.
  • Review significant product submissions with manager and negotiate submission issues with agency personnel.
  • Assist in negotiations with FDA and/or international regulatory agencies on assigned projects/products.
  • Support regulatory compliance activities, including manufacturing site registration, audits, annual reporting, as needed.
  • Monitor and analyze regulatory trends and changes, providing strategic guidance to cross-functional teams.
  • Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
  • Ensure personal understanding of all quality policy/system items that are personally applicable.
  • Follow all work/quality procedures to ensure quality system compliance and high-quality work.
  • Maintain regulatory documentation to ensure compliance.
  • Manage multiple projects, prioritize daily tasks, and ensure project deadlines are met.
  • Contribute to continuous improvement and process optimization initiatives within the department.

Requirements

  • Bachelor’s degree required with a Minimum of 4 years of experience in medical device regulatory affairs experience
  • Advanced degree with 2 years of experience
  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
  • Experience with heart valve products
  • Experience with Software as a Medical Device
  • RAC Medical Device Certification
  • Experience with Class II/III (510(k), PMA, IDE) and EU MDR medical device submissions
  • Experience with assessment and reporting of product changes according to US and EU regulatory requirements
  • Product development experience
  • Clinical or statistical experience
  • Experience with FDA and international regulatory agency requirements, ISO/GHTF standards
  • Ability to comprehend principles of engineering, physiology and medical device use
  • Excellent communication, negotiation, and problem-solving skills.
  • Effective interpersonal skills and team member
  • Ability to effectively manage multiple projects and priorities in a fast-paced environment
  • Detail oriented
  • Proficient computer skills
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 strategiesregulatory complianceregulatory documentationmedical device regulatory affairsClass II/III submissionsEU MDR submissionsSoftware as a Medical Deviceproduct developmentclinical experiencestatistical experience
Soft skills
communication skillsnegotiation skillsproblem-solving skillsinterpersonal skillsteam collaborationproject managementdetail orientedability to manage multiple projectsstrategic guidancecontinuous improvement
Certifications
Bachelor's degreeAdvanced degreeRAC Medical Device Certification