Global Ivd Regulatory Affairs Specialist

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.
We are the people who give possibilities purpose
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 MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
The Regulatory Affairs Specialist supports global regulatory activities for in vitro diagnostic (IVD) medical devices throughout the product lifecycle. This role is responsible for contributing to regulatory strategy development, regulatory submissions, product registrations, technical documentation, regulatory intelligence, change management assessments, and compliance activities to ensure continued market access worldwide.
The position partners closely with cross-functional teams including Research & Development, Quality Assurance, Manufacturing, Clinical Affairs, Medical Affairs, Operations, and Marketing to ensure regulatory requirements are incorporated into product development, maintenance, and commercialization activities.
The ideal candidate possesses a scientific background, strong analytical skills, and the ability to independently assess regulatory requirements, evaluate regulatory risks, and translate evolving regulatory requirements into actionable business recommendations.
Key Responsibilities
+ Develop, maintain, and support global regulatory strategies for in vitro diagnostic (IVD) devices throughout the product lifecycle.
+ Prepare, review, compile, and maintain regulatory submissions, product registrations, technical documentation, declarations of conformity, and supporting regulatory records to support global market access.
+ Support compliance with applicable global regulatory requirements, including FDA regulations, EU IVDR (EU) 2017/746, UK regulations, Health Canada requirements, and other international regulatory frameworks.
+ Conduct regulatory impact assessments and support change management activities related to product, manufacturing, supplier, software, labeling, design, process, clinical, and post-market changes.
+ Monitor evolving regulations, standards, guidance documents, and regulatory intelligence, and communicate regulatory impacts and recommendations to internal stakeholders.
+ Partner with cross-functional teams including R&D, Clinical Affairs, Quality Assurance, Manufacturing, Medical Affairs, and Marketing to ensure regulatory requirements are incorporated throughout product development and lifecycle management activities.
+ Review product labeling, Instructions for Use (IFUs), promotional materials, and other product-related documentation for regulatory compliance.
+ Support interactions with regulatory authorities, Notified Bodies, Competent Authorities, and other regulatory agencies, including preparation of submissions and responses to regulatory inquiries.
+ Support product lifecycle management activities, including change control assessments, market expansions, performance studies, evidence generation, vigilance reporting, field actions, and regulatory maintenance activities.
+ Support internal and external audits and inspections, maintain regulatory procedures and quality system documentation, and provide regulatory training and guidance to stakeholders.
Required Qualifications
+ Bachelor's degree in Biology, Biotechnology, Biomedical Sciences, Pharmacy, Life Sciences, or a related scientific discipline. Master's degree in Regulatory Affairs, Cell Biology, Health Sciences, Health Administration, Biotechnology will be a plus.
+ 1-3 years of professional experience in Regulatory Affairs, Quality, Medical Devices, IVDs, Life Sciences, or a related field.
+ Strong written and verbal communication skills