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Regulatory Affairs Specialist II

Oro Valley, AZ 85755

Posted: 10/16/2023 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 11446 Pay Rate: $32.00 - $43.00

Job Description

Our client develops, manufactures, and supplies a wide array of innovative medical diagnostic products, services, tests, platforms, and technologies.

Responsibilities:
  • Works under moderate guidance and is responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company.
  • Compiles materials required in submissions, license renewals and annual registrations.
  • Keeps abreast of regulatory procedures and changes.
  • Coordinates the collection of documents, records, reports, and data from the Development, Clinical Affairs, Quality, and Operations Departments for inclusion in regulatory documents.
  • Assists in the preparation of international registration dossiers for use in international registration our client's Affiliates.
  • Support countries' requests.
  • Participates with internal/external teams and builds professional relationships.
  • Identifies and suggests solutions to Regulatory tasks.

Job Requirements

Qualifications:
  • To perform this job successfully, an individual must be able to perform each responsibility satisfactorily.
  • The requirements listed below are representative of the knowledge, skills, and/or abilities required.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
  • 5 years of related Regulatory Affairs experience.
  • Bachelor's Degree preferred.

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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