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Global Regulatory Affairs Specialist II
2 months ago
We are seeking a highly skilled Regulatory Affairs Specialist 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, 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 the set up and management of outside vendors, such as license holders and in-country agents.
- Monitor global regulatory intelligence and provide impact evaluations to changing regulations.
- 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.
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 directly in 35 countries, with products available in over 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
