Sr. Regulatory Affairs Specialist

Location: Connecticut, United States
Salary: competitive
Job Type: Permanent
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Location: Connecticut (greater Hartford area)

Length: Full time/Perm role (6 month initial contract to be converted to permanent)

Must be W2; we are able to offer benefits during contract period (medical/dental/vision/401k) Sr. Regulatory Affairs Specialist

  • Facilitates regulatory-based projects with assistance from Regulatory Affairs Senior Director
  • Previews and reviews change notices to assess regulatory status impact
  • Reviews documentation required to support various regulatory activities
  • Assists with regulatory approval application preparation and submission process
  • Reviews labelling and promotional materials to ensure compliance with FDA, EU (European Union) and other international requirements
  • Assists with FDA customs import/export requests, customer service needs, and other requests from internal or external customers
  • Initiates and updates technical files/registrations

Qualifications/Requirements:

  • Bachelor's degree or Master's degree
  • At least 4 - 7 years regulatory affairs experience in the medical device industry
  • Experience working with health ministries and agencies, including the FDA and EU (European Union)
  • In-depth knowledge of medical device regulations
  • Experience implementing regulations into Quality Systems
  • Regulatory Affairs Professional Society (RAPS) certification is a plus
  • PMA experience is a plus
  • Strong written and verbal communication skills is a must

Sthree US is acting as an Employment Agency in relation to this vacancy.

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