Sr. International Regulatory Affairs Specialist

Senior International Regulatory Affairs Specialist

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.

Position Summary : We are seeking a Sr. International Regulatory Affairs Specialist to join our 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.

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 :

Preferred Skills / Experience :

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.

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.

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.