Sr. International Regulatory Affairs Specialist

Becton Dickinson Medical Devices • Milpitas, CA

1d • Onsite

About The Position

The Senior Regulatory Affairs Specialist leads and independently executes international regulatory affairs activities with primary accountability for maintaining product registrations in LATAM and APAC markets, owning Notification of Change (NoC) regulatory activities, and driving regulatory intelligence for countries outside the U.S. and EU. This role ensures sustained market access through proactive management of registrations, assessment and coordination of regulatory change impacts, clear communication of country status and risks, and initiation or release of country specific ship/hold actions in collaboration with cross functional stakeholders. The position provides regulatory guidance across the organization, supports audits and process improvement activities, and monitors evolving global regulatory requirements to assess business impact and inform regulatory and compliance strategies for IVD and RUO products. We are the makers of possible 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. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 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.

Requirements

• Bachelor’s degree in a scientific, engineering, or medical discipline (e.g., biology, chemistry, biomedical, engineering, life sciences, or related field), or equivalent combination of education and experience.
• Excellent interpersonal skills with proven track record of building effective relationships internally and externally.
• Minimum of 5–8 years of regulatory affairs experience within the medical device and/or in vitro diagnostics (IVD) industry.
• Demonstrated experience supporting international regulatory submissions, approvals, and maintenance of registrations, preferably including LATAM and/or APAC markets.
• Experience assessing and managing regulatory impact of product or process changes, including participation in Notification of Change (NoC), ACR, or equivalent change‑control processes.
• Working knowledge of global IVD regulatory requirements and standards (e.g., ISO 13485, international registration pathways, labeling and post‑approval requirements).
• Proven ability to work independently, manage multiple priorities, and collaborate effectively with cross‑functional teams in a regulated environment.
• Excellent interpersonal skills with proven track record of building effective relationships internally and externally.
• Strong interpersonal and communication skills, with the ability to effectively collaborate and influence cross‑functional stakeholders at multiple organizational levels.
• Demonstrated ability to clearly communicate regulatory status, risks, and requirements to technical and non‑technical audiences.
• Strong organizational and project management skills, with the ability to manage multiple priorities in a fast‑paced, matrixed environment.
• Proven analytical and problem‑solving skills, including the ability to assess regulatory impact and develop practical, compliant solutions.
• High attention to detail with a commitment to accuracy, completeness, and regulatory compliance.
• Ability to work independently with limited supervision while exercising sound professional judgment.

Nice To Haves

• Master’s Degree Preferred.
• Bilingual proficiency in Chinese/Mandarin is beneficial but not essential.
• RAC (Regulatory Affairs Certification) a plus.

Responsibilities

• Prepares and/or compiles information required by international regulatory associates to register or license products outside the EU particularly in the LATAM and APAC regions.
• Monitors and maintains country licenses for the LATAM and APAC countries.
• Represent the International Regulatory Affairs team in cross-functional project teams.
• Provide guidance to other departments within the organization and/or product development teams on matters relating to regulatory requirements for the rest of the world outside of US and EU.
• Develop and execute international regulatory strategies for IVD device registrations outside the U.S. and EU.
• Own and coordinate Notification of Change regulatory activities for countries outside the U.S. and EU including but not limited to: Communication of NoC/Registration status; serve as the International RA point of contact for country market access status; maintain oversite of country readiness (submission/approval requirements and status); initiate/release country specific ship hold decision.
• Responsible for conducting regulatory intelligence activities to monitor and interpret global regulatory trends, guidance documents, and emerging regulations relating to medical device industry; keep up-to-date records of key events occurring within sector; identify implications arising from new policies implemented by governments; assess impact on current operations; devise plans accordingly so as not to disrupt normal functioning of business units.
• Provide regulatory support during internal and external audits.
• Assist in development of regulatory procedures and SOP’s.
• Support regulatory integration activities by coordinating documentation , aligning processes, and ensuring compliance with integration plans.

Benefits

• At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees