Regulatory Affairs Specialist

7 days ago


Naples, Florida, United States Lifelancer Full time

At Lifelancer, we connect talented professionals with opportunities in life sciences, pharma, and IT. This role is a critical part of our platform.

Salary and Benefits

This position comes with a competitive salary ranging from $90,000 to $145,000 per year, reflecting the expertise required for this role. Additionally, you will enjoy a comprehensive benefits package, including medical, dental, and vision insurance, company-provided life insurance, flexible spending accounts, and more.

About the Job

This Senior Specialist, Regulatory Affairs role plays a vital part in managing product activities related to regulatory submissions and registration for Arthrex's Digital Innovation product lines. Your primary responsibilities will include:

  • Developing U.S., EU, and Canada regulatory strategies and implementation plans for new products and reviewing proposed changes for impact on regulatory strategy and status.
  • Evaluating the risk of proposed regulatory strategies and offering solutions as applicable.
  • Advising and providing regulatory direction to assigned Product Development Teams on regulatory requirements, documentation, and testing needed for FDA, EU MDR & Health Canada regulatory submissions and registrations.
  • Preparing, writing, and submitting FDA, Notified Body, and Health Canada submissions for new products and product changes within established timelines and submission dates.
Requirements and Qualifications

To be successful in this role, you should have:

  • A minimum of 5 years' experience in a regulatory affairs role in the life science industry, preferably in orthopedic medical devices.
  • A Bachelor's degree in an engineering or science discipline, with an advanced degree preferred.
  • Experience authoring and submitting medical device registrations/licenses/submissions applicable to regional areas.
  • Ability to comprehend and apply mathematical principles and language skills to perform the job based on requirements.

As a remote position, you will have the flexibility to work anywhere in the United States while collaborating with our global team.



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