Regulatory Affairs Specialist

1 week ago


Saint Paul, Minnesota, United States RTA US Full time
Job Title: Regulatory Affairs Specialist

RTA US is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with global regulatory requirements for medical devices and drug products.

Responsibilities:
  • Redline medical device labeling based on global requirements, reviewing and approving final labeling in internal systems.
  • Update documentation in technical files related to new legal manufacturer name and address, and route documents for approval in company internal document database.
  • Field requests from global regulatory associates for registrations, locate and send requested documentation to global team for in-country submissions.
Requirements:
  • Bachelor's Degree or higher from an accredited university in a technical field such as Biology, Chemistry, Pharmacology, Biochemistry, etc.
  • 2-3 years of experience in regulatory affairs in the medical device industry.
  • Direct experience authoring technical documentation.
  • Direct experience reviewing and approving product labels and instructions for use for medical devices.
  • Experience supporting international registrations.
  • Fluency in English and German.
What We Offer:

RTA US offers a comprehensive benefits package, including medical, dental, and vision plans, supplemental coverage, 401(k) retirement savings, life and disability insurance, employee assistance program, legal support, auto and home insurance, pet insurance, and employee discounts.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.



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