Regulatory Affairs Specialist (Innovation

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics.

Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for in vitro diagnostic (IVD) products. This position will be responsible for preparing FDA submissions, including, but not limited to:
Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications, as well as EU IVDR Technical Files/Dossiers.

Responsibilities:

• Serves as Regulatory Affairs SME on various new product development (NPD) teams
• Works cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management and other key organizational functions
• Recognizes and addresses potential regulatory risks with project plans
• Responsible for organizing and leading various FDA & EU IVDR submissions
• Serves as contact to FDA and Notified Body review teams during submission reviews/communication
• Recognizes and proposes continuous process improvements.

Required

Education and Experience:

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline (Equivalent combination of education and relevant experience may be considered)
• Minimum5 years of directly related regulatory experience in the in vitro diagnostic device and/or medical device area(s)

Preferred

Skills and Experience:

• RAPS Certification preferred
• Demonstrated experience in interpreting subjective and complex aspects of specific regulations
• Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
• Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change
• Demonstrated success in preparing, filing and/or completing (including negotiations) regulatory submissions

Skills

• Ability to analyze complex issues and to formulate sound approaches to resolving/addressing issues
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs. Minimal supervision required.

Technical & Functional:

• Experience coordinating cross-functional inputs (i.e. R&D, Quality, Medical Affairs, Program Management, Marketing)
• Ability to compile and review documentation to support FDA submissions and EU IVDR documentation
• Understanding of regulatory submission processes and lifecycle management

Communication &

Collaboration:

• Strong written and verbal…