Regulatory Affairs Specialist II

2 months ago


Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Waters Corporation. As a key member of our Clinical Business Unit, you will be responsible for providing regulatory support to new product development teams, ensuring compliance with global regulations and standards.

Key Responsibilities
  • Develop and maintain regulatory strategies for new and modified products, ensuring compliance with 21 CFR 820 and ISO 13485.
  • Prepare and execute regulatory filings, including technical files, Canadian submissions, and letters to file.
  • Conduct international registrations in accordance with and in support of regulatory strategies.
  • Provide input on and approve product labels and labeling, including language requirements worldwide.
  • Support set up and management of outside vendors, including license holders and in-country agents.
Requirements
  • Bachelor's degree in Analytical Chemistry, Biochemistry, or Biomedical Engineering, or equivalent.
  • Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalent.
  • Knowledge and application of 21 CFR 820 and ISO 13485 is required.
  • Knowledge and application of the European IVD regulations is required, IVDR preferred.
What We Offer

At Waters Corporation, we offer a dynamic and inclusive work environment, with opportunities for professional growth and development. We are committed to equal employment opportunity and are an affirmative action employer.



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