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Regulatory Specialist

3 months ago

Maple Grove, United States Insight Global Full time

Job Title: Regulatory Affairs Specialist II

Location: Maple Grove, MN

Pay range: $88,020 to $107,000

Work mode: Hybrid (Tuesday's onsite)


Day to day:

Insight Global is looking for a Regulatory Affairs Specialist II to join their Peripheral Interventions team. This candidate is acting as a product owner and is responsible for regulatory affairs support on a global stance. They will work with the EU and international regulatory partners and represent regulatory on project teams. They will be apart of the product development process, integration of acquired products and ongoing regulatory compliance. This candidate will be spending 60% of their day conducting independent work, reviewing emails etc. The remainder of the time will be spent with project teams representing regulatory within R&D, PI, Vascular, and Operation's engineers. This candidate will start out by reviewing changes to existing class II and class III devices. This role has a pay range of 88-105k salary depending on experience.


Must Haves:

  • Bachelors degree in a scientific or technical degree. Ex: regulatory affairs, biomedical, biology, handful of technical communications, technical writing, and microbiology.
  • 3 years of medical device experience and 2 years of regulatory affairs experience.


Plusses:

  • 1 year of regulatory experience if its relevant to their risk classifications, for medical devices for class III, involved with 10k's.