Job Description Summary

We are seeking a Senior International Regulatory Affairs Specialist to join our Regulatory Affairs team. This role is responsible for preparing and managing regulatory submissions to support the global commercialization of new or modified in vitro diagnostic (IVD) devices. The ideal candidate will have strong experience in international regulatory strategy, submission development, and cross-functional collaboration.

Job Description

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. 

Position Summary:

We are seeking a Sr. International Regulatory Affairs Specialist to join our Regulatory Affairs team. This role is responsible for preparing and managing regulatory submissions to support the global commercialization of new or modified in vitro diagnostic (IVD) devices as well as research use only (RUO) products. The ideal candidate will have strong experience in international regulatory strategy, submission development, and cross-functional collaboration. This position requires identifying required documentation, management of submission to worldwide RA partners and working with cross functional teams to ensure that all data and information required for regulatory submissions and approvals are generated.

Key Job responsibilities:

• Develop and execute international regulatory strategies for IVD device registrations outside the U.S. and EU.

• Gather information from international counterparts regarding submission pathways and impact of changes and support international counterparts in global regulatory submissions/approval.

• Prepare, coordinate, and manage regulatory submission documents for new products, renewals, and changes to existing products.

• Ensure compliance with global regulations and guidelines.

• Lead responses to regulatory agencies during submission and approval processes.

• Represent Regulatory Affairs in cross-functional product development teams.

• Evaluate design, manufacturing, and process changes for global regulatory impact.

• Review analytical and clinical protocols to ensure appropriate data collection for submissions.

• Review and approve product labels, labeling, and promotional materials for regulatory compliance.

• Provide regulatory support during internal and external audits.

• Conduct regulatory intelligence activities to monitor, analyze, and communicate evolving regulatory requirements in countries outside the U.S. and EU.

• Maintain awareness of international regulatory trends, guidance documents, and standards relevant to IVDs.

• Collaborate with regional RA teams and consultants to ensure timely updates and strategic alignment with local regulatory expectations.

Required Skills/Experience:

• Bachelor’s degree (± 15 years), in science, math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience.

• ± 17 years in the medical device, diagnostics, biologics, or pharmaceutical industry, with a focus on regulatory affairs.

• Ability to work in a fast-paced environment and handle multiple projects simultaneously.

• Demonstrated ability to interpret and apply global IVD regulatory requirements.

• Experience with IVD and/or Medical device country registration/submission.

• Familiarity with ISO 13485/900, EU IVDR and US FDA 510 requirements.

• Experience with reviewing and approving product labeling, advertising and IFU’s

• Excellent interpersonal skills with proven track record of building effective relationships internally and externally.

• Strong written and verbal communication skills across all organizational levels.

• Effective project management skills with the ability to prioritize and multitask.

• Strong analytical skills coupled with ability to think critically and solve problems independently.

• Detail-oriented with a proactive approach to problem-solving.

Preferred Skills/Experience:

• RAC (Regulatory Affairs Certification) a plus.

• Master’s Degree (± 17 years), Preferred

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

Required Skills

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Primary Work Location

USA CA - Milpitas 135

Additional Locations

Work Shift

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.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information