Senior Regulatory Affairs Specialist

4 weeks ago


Mansfield Center, Massachusetts, United States Medtronic Full time

Job Summary

Medtronic is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for planning and executing regulatory strategy for molding and capital tooling projects, assessing the regulatory impact of post-marketing changes, and leading project teams through the regulatory requirements.

Key Responsibilities

  • Plan and execute regulatory strategy for molding and capital tooling projects
  • Assess the regulatory impact of post-marketing changes
  • Lead project teams through the regulatory requirements
  • Direct or perform coordination and preparation of document packages for regulatory submissions
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance

Requirements

  • Bachelor's degree with 4+ years of experience in regulatory affairs
  • Advanced degree with 2+ years of experience in regulatory affairs
  • 4+ years of experience in medical device regulatory affairs
  • US and global regulatory affairs knowledge and submission experience
  • Advanced degree in engineering or regulatory affairs
  • Microsoft Word, Excel, and Adobe software skills
  • Experience with project management and adherence to time schedules
  • Team player who seeks to help and learn from colleagues
  • Ability to manage projects to completion within and outside of the direct department and company
  • Proactively seeks to develop and become well-versed within the regulatory landscape
  • RAPS Regulatory Affairs Certification (RAC)

What We Offer

  • Competitive salary and flexible benefits package
  • Short-term incentive called the Medtronic Incentive Plan (MIP)
  • Opportunity to work with a global team of 90,000+ passionate people
  • Chance to advance healthcare, society, and equity with every design, inside and outside our walls

Equal Employment Opportunity

Medtronic is an equal employment opportunity employer and will provide reasonable accommodations for qualified individuals with disabilities.



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