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