Global 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 Regulatory Affairs department, you will be responsible for providing regulatory support to new product development teams to ensure compliance with regulatory requirements.

Key Responsibilities
  • Regulatory Support
    • Act as Regulatory Affairs lead for new product development projects, providing strategic guidance to development teams.
    • Develop and maintain regulatory strategies for new and modified products.
    • Prepare and execute regulatory filings, including technical files and submissions.
    • Conduct international registrations in accordance with regulatory strategies.
    • Provide input on and approve product labels and labeling.
  • Change Management
    • Provide regulatory guidance on changes to existing products.
    • Monitor global regulatory intelligence and provide impact evaluations.
    • Perform regulatory impact assessments for engineering changes.
    • Review and approve promotional materials.
  • Post Market
    • Provide regulatory input to support post market surveillance and vigilance activities.
    • Support Health Hazard Assessments and Field Actions as needed.
Qualifications
  • Education
    • Bachelor's degree required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering.
  • Experience
    • Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment.
    • Knowledge and application of 21 CFR 820 and ISO 13485.
    • Knowledge and application of the European IVD regulations.
  • Skills
    • High fluency in English, verbal and written.
    • Critical Thinking, Active Listening, and Technical Writing Skills.
    • Able to work effectively in a global function.
About Waters Corporation

Waters Corporation is a leading specialty measurement company that has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, and food sciences for over 60 years. We operate globally with a team of over 7,000 employees and a presence in over 100 countries. Our mission is to create business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.

We are committed to diversity and inclusion and strive to create an inclusive work environment that values and respects the contributions of all employees. We are an equal opportunity employer and welcome applications from diverse candidates.

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