Regulatory Affairs Specialist II
2 months ago
About the Role
Waters Corporation is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory guidance and support for new product development projects.
Responsibilities
- Develop and maintain regulatory strategies for new and modified products/product families
- Prepare and execute regulatory filings such as 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 such as License holders and In Country agents [including importers, distributors], as needed
Change Management
- Provide regulatory guidance on changes to existing products
- Monitor global regulatory intelligence, provide impact evaluation to changing regulations
- Performing 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
- Bachelor's degree required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education is preferable
- 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
- First-hand experience with preparation and execution of regulatory filings such as pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval, preferably for clinical IVD products
Skills
- High fluency in English, verbal and written
- Critical Thinking, Active Listening, and Technical Writing Skills
- Able to work effectively in a global function
- Strong ability to work with individuals/teams dispersed across many different locations and cultures
- Strong organization/prioritization skills
- Outstanding Work Ethic
- Effective communication and influencing skills
- Team player demonstrating good organizational and communication skills
- Self-starting demonstrating initiative
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