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Regulatory Affairs Specialist

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Russell Tobin & Associates

2024-09-25 07:37:46

Job location Saint Paul, Minnesota, United States

Job type: fulltime

Job industry: Government & Defence

Job description



What are we looking for in our Regulatory Affairs Specialist?

Russell Tobin's client, a food safety business is hiring a Regulatory Affairs Specialist to work remotely

Apply Now!

Employment Type: Contract/Remote

Pay rate: $33-$35/hr. DOE

Role Info:

In this regulatory affairs specialist position, you will have the opportunity to participate in a global healthcare spin off and act as a contributing member for one of the regulatory affairs teams at the division level. The role will have a significant impact on country registrations and labeling changes that are needed for medical devices, and some drug products, here at Client. The position will work with the international regulatory affairs group to ensure products are registered globally based on the spinoff strategy.

Responsibilities:

  • Redlining medical device labeling based on global requirements per label checklist, reviewing and approving final labeling in internal systems
  • Updating documentation in technical files related to new legal manufacturer name and address and routing documents for approval in company internal document database
  • Fielding requests from global regulatory associates for registrations, locating and sending requested documentation to global team for in country submissions.

Your Skills and Expertise:

  • Bachelor's Degree or higher from an accredited university in a technical field such as Biology, Chemistry, Pharmacology, Biochemistry, etc.
  • 2-3 years 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.

Qualifications that will help you succeed in this role include:

  • Attention to detail: Meticulously evaluate information and ensure compliance.
  • Critical thinking: Assess products and substances, understand regulations, and solve problems.
  • Time management: Meeting deadlines in this role is critical.
  • Compliance document creation: Preparing necessary compliance documents.
  • Product assessment: Evaluating products and labeling.

Benefits that Russell Tobin offers:

Russell Tobin offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

Rate/Salary: $33-$35/hr. DOE

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