Waters Regulatory Affairs Specialist II in Milford, Massachusetts
The Regulatory Affairs Specialist II has primary responsibility 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 for IVD general-purpose use analytical instrumentation such as LC/MS/MS techniques.
Develop regulatory strategies for new and modified products in markets such as the US & Canada, EU & the Middle east, China & APAC, LATAM, and the ROW.
Asses device changes and impact on company’s worldwide registrations
Preparing regulatory filings such as pre-Submissions, premarket notifications, technical files, Canadian submissions and letters to file Perform regulatory research as needed in the areas of device technologies, competitors, and regulatory intelligence
Review and approve promotional materials and device labeling Maintain global establishment registrations and device listings
Assist with filing field action reports and correspondence with regulatory agencies Be an active member in the IVDR roll out sub-teams.
Fulfill requests for documentation to support international regulatory submissions
- Minimum of a bachelor’s degree in analytical chemistry, biochemistry or biomedical engineering. A graduate degree is preferable
3-5 years’ experience in in Vitro Diagnostic Medical Device environment, preferably industry experience within Clinical IVD
Previous experience preparing regulatory filings such as pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval, preferably for clinical IVD products
Knowledge of 21 CFR 820, ISO 13485, and ISO 14971 is required Knowledge of the US and European IVD regulations required Knowledge of other international regulations is a plus
Self-starting demonstrating initiative
Critical Thinking, Active Listening, and Technical Writing Skills required RAC a plus
Ability to collaborate effectively within and outside of team, possessing strong interpersonal and communication skills to work effectively with superiors, peers, and customer
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.
Company Name: Waters Division
External Company URL: www.waters.com
Street: 34 Maple Street
Recruiter Assigned: Claire Breton