Regulatory Affairs Specialist

21 hours ago

Saint Paul, Minnesota, United States RTA US Full time
Job Description

Russell Tobin's client, a leading food safety business, is seeking a highly skilled Regulatory Affairs Specialist to join their team on a contract/remote basis.

Job Summary:

We are looking for a detail-oriented and organized Regulatory Affairs Specialist to support our global healthcare spin-off. The successful candidate will be responsible for ensuring compliance with regulatory requirements for medical devices and some drug products. This role will work closely with the international regulatory affairs group to ensure products are registered globally based on the spin-off strategy.

Key Responsibilities:

  • Review and approve medical device labeling based on global requirements
  • Update documentation in technical files related to new legal manufacturer name and address
  • Field requests from global regulatory associates for registrations and locate/send requested documentation for in-country submissions

Requirements:

  • Bachelor's Degree or higher 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:

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

About Us:

Russell Tobin is a minority-owned business that delivers exceptional service to its clients and candidates by capitalizing on diverse recruiting, account management, and staffing backgrounds. Our personalized approach within the industry shines through as we continue cultivating honest and open relationships with our network of healthcare professionals, creating an unparalleled environment of trust and loyalty.

Equal Employment Opportunity Statement:

Russell Tobin is an equal opportunity employer and is committed to creating a diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.

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