Medtronic

Senior Regulatory Affairs Specialist

Medtronic

full-time

Posted on:

Location Type: Hybrid

Location: Santa Clara • California • Colorado • United States

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Salary

💰 $103,200 - $154,800 per year

Job Level

Senior

About the role

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
  • Leads or compiles all materials required in submissions, license renewal and annual registrations
  • Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities including design changes
  • Write, update and maintain technical documentation
  • Review promotional material for accuracy and compliance
  • Keeps abreast of regulatory procedures and changes
  • May direct interaction with regulatory agencies on defined matters
  • Recommends strategies for earliest possible approvals of clinical trials applications.

Requirements

  • Bachelor’s degree required
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
  • Experience in the medical device industry
  • Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation)
  • Excellent attention to details, proactive approach and ability to work independently
  • High learning agility and ability to work under pressure
  • Detail-oriented and organized, capable of managing multiple priorities while meeting strict regulatory deadlines.
  • For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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 & Tools
regulatory submissionstechnical documentationclinical trials applicationslicense renewalannual registrationspost-market activitiesdesign changespromotional material reviewregulatory proceduresglobal regulatory frameworks
Soft Skills
attention to detailproactive approachindependent worklearning agilityability to work under pressuredetail-orientedorganizational skillsmanaging multiple prioritiesmeeting deadlines
Certifications
Bachelor's degreeadvanced degree