BD · 1 month ago
International Regulatory Affairs Specialist
United States
Full-time
Remote
Mid Level
$76K/yr - $121K/yr
2+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health. The International Regulatory Affairs Specialist will collaborate with regional colleagues to develop strategies for regulatory submissions worldwide and support product registration requests while ensuring compliance with regulations.
HealthcareMedical DeviceHealth CareTechnical Support
No H1B
Responsibilities
Coordinates and collects specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments, as necessary to support registration requirements
Interfaces with OEMs to collect specific registration information
Assembles technical information to create a 'clinical report' or a 'dossier'
Acts as lead for key countries, as identified, managing each request to completion
Recognizes and proposes continuous process improvements
Develops and maintains departmental procedures (SOP's and work instructions) for international product registrations
Qualification
Required
Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline (Equivalent combination of education and relevant experience may be considered)
Experience coordinating cross-functional inputs (R&D, QA, Manufacturing, Marketing)
Ability to compile and review technical documentation in accordance with country-specific requirements
Understanding of regulatory submission processes and lifecycle management
Strong written and verbal communication skills
Experience working with global teams, regional affiliates, or distributors
Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485)
Ability to identify and support process improvements
Strong organizational skills and ability to manage multiple submissions/projects simultaneously
Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)
Preferred
Experience supporting international (ex-U.S.) regulatory submissions and product registrations
Minimum 2–5 years of regulatory affairs experience, preferably in medical devices, pharmaceuticals, or healthcare products
Regulatory Affairs Certification (RAC)
Experience acting as country lead or project lead for registrations
Exposure to OEM/private label compliance requirements
Knowledge of UDI, labeling, and post-market regulatory activities
Working knowledge of global regulatory requirements (e.g., EU MDR/IVDR, Canada, LATAM, APAC markets)
Familiarity with technical documentation, dossiers, and clinical evaluation reports
Benefits
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program.
We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
You can learn more on our career site under "[Our Commitment to You](https://jobs.bd.com/en/your-career-at-BD)."
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$1.25BKey Investors
Steris
2026-05-11Post Ipo Debt· $706.77M
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Thomas Polen
Chairman, CEO and President
Vitor Roque
Executive Vice President, Chief Financial Officer
Recent News
2026-07-10
2026-07-10
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