Overview
The Regulatory Affairs Specialist II has primary responsibility for provision of In Vitro Diagnostic regulatory support to new product development teams to ensure product requirements/design inputs and design outputs enable identified planned regulatory filings.
Prepare, execute and maintain regulatory filings including change management, support of post market requirements and support of outside vendors [e.g. license holders, in country representatives].
The role will work through multiple levels and across functions within the Clinical Business Unit organization to support the growth of the IVD product portfolio.
Responsibilities
New Product Development
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- Act as Regulatory Affairs lead for the new product development projects, provide "solution-based" advice to development teams
- Develop and maintain regulatory strategies for new and modified product / 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 labelling 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
Education:
- Bachelor's degree required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education is preferable.
Experience:
- 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
Company Description
Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 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.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We're the problem solvers and innovators that aren't afraid to take risks to transform the world of human health and well-being. We're all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.