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Senior Specialist-Structural Heart

  • Job type: Permanent
  • Location: Maple Grove, Minnesota
  • Salary: US$85000 - US$105000 per year
  • Job reference: 329721/001_1560351164
  • Sector: EPM Scientific, Regulatory
  • Date posted: 12/06/2019

Are you interested in working on cutting edge technologies in the fast-paced cardiovascular medical device space?

My client has been a global medical technology leader for the past 35 years. This medical device company is looking for someone to join their regulatory team as a Senior Specialist.

They are looking for a dynamic individual focused on professional development in an innovative environment offering a diverse mix of regulatory opportunities encompassing the full life cycle of both lower risk and high risk cardiovascular devices.

Qualifications

  • BA/BA Degree in Life Sciences, engineering or an equivalent
  • Minimum of 4 years of regulatory affairs experience within the medical device(high risk preferred)
  • Experience in planning, preparation, and submission of 510(k)s, technical files and design dossiers is required.
  • Gold stars if you have Class III U.S. submissions experience
  • International experience a plus
  • Experience working with FDA, Notified Bodies and/or international health authorities
  • Team player with excellent interpersonal skills
  • Ability to travel at least 15%

Tons of perks and benefits!

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