Waters Senior Regulatory Affairs Specialist in Milford, Massachusetts
The Senior Regulatory Affairs Specialist has primary responisibility for providing In Vitro Diagnostic regulatory guidance to products new product development teams, preparing regulatory filings, reviewing promotional materials, supporting health hazard assessments, reviewing design change assessments, mentoring Regulatory Specialists and project management of assigned regulatory programs.
Participate as a core team member on new product development teams providing regulatory guidance.
Lead the IVDR transition activities.
Provide regulatory guidance for changes to existing products
Develop and maintain regulatory strategies for new and modified products.
Lead Regulatory Affairs intelligence team and update RA strategy template with new worldwide regulations.
Preparing regulatory filings such as pre-IDEs, premarket notifications, technical files, Canadian submissions and letters to file.
Manage and maintain Regulatory Affairs internal policies and procedures.
Perform regulatory research as needed.
Performing regulatory impact assessments for engineering changes.
Review and approve promotional materials.
Support Health Hazard Assessments and Field Actions as needed.
Support international registrations as needed.
Provide guidance to regulatory specialists as needed.
Bachelor’s degree required preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education is preferable.
5+ years regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalent.
Knowledge of 21 CFR 820 and ISO 13485 is required.
Knowledge of the US and European IVDR regulations is required.
Knowledge of LC/MS and Software regulations is a plus.
Team player demonstrating good organizational and communication skills
Self-starting demonstrating initiative
- Ability to travel 5-15%
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 60 years. With approximately 7,000 employees worldwide, Waters operates directly in 31 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.
Waters Corporation's businesses include Waters, TA Instruments, VICAM, ERA, and Nonlinear Dynamics.
Waters creates business advantages for laboratory-dependent organizations by delivering ultra performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry systems, laboratory informatics solutions, and comprehensive service programs to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Diversity and inclusion are fundamental to our core values at Waters Corporation. Celebrating diversity is important to us. We 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.
regulatory affairs, ISO 13485, 21 CFR 820, IVDR, regulatory filings
Company Name: Waters Division
External Company URL: www.waters.com
Street: 34 Maple Street
Telecommute: Negotiable - Flexwise