Regulatory Affairs Expert with Medical Device Experience

7 days ago


Indianapolis, Indiana, United States Lifelancer Full time
Job Overview

Lifelancer is a leading talent-hiring platform in Life Sciences, Pharma and IT. We are currently seeking an experienced Regulatory Affairs Specialist to join our team.

Responsibilities
  • Collaborate with internal departments to efficiently meet regulatory requirements for medical devices.
  • Develop and implement regulatory policies, processes, and SOPs.
  • Determine submission and approval requirements for assigned geographies.
  • Provide input on regulatory requirements to product development and operations teams.
Requirements

We are looking for a highly skilled Regulatory Affairs Specialist with:

  • A minimum of 10 years of related experience with a Bachelor's degree or 8 years with a Master's degree.
  • In-depth knowledge of domestic and international regulatory guidelines, policies, and regulations.
  • Experience with pre- and post-market medical device submissions.
Salary Range

The estimated salary range for this position is $102,000 - $128,000 per year, based on location and qualifications.

Benefits

We offer a competitive total compensation package, including medical, dental, vision, and retirement benefits, as well as perks such as pet insurance and spot bonus awards.



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