Senior International Regulatory Affairs Specialist

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Responsibilities:

The Senior International Regulatory Affairs Specialist will be responsible for partnering in the preparation and approval of regulatory submissions of medical devices worldwide.

Job Responsibilities:

• Leads collecting, compiling, and analyzing, country specific regulatory requirements
• Drives international registrations according to project plan
  • Reviews and approves technical documentation to ensure required information and data for regulatory submissions are included.
  • Prepares and/or compiles information required by international regulatory associates to register or maintain registration of products in international regions.
  • Collaborates with cross-functional teams for preparation of additional data/information requested by notified body/ regulatory agencies and prepares appropriate responses to all requests.
• Navigates, interprets, and applies Design History File (DHF)/Technical File (STED) content to assess regional applicability and support international regulatory submissions.
• Develops and executes regulatory strategies for product registrations, renewals, and lifecycle changes to support business objectives and market access requirements.
• Proactively identifies regulatory risks, assesses potential business impact, develops mitigation plans, and escalates critical issues in a timely manner to enable effective decision-making and maintain project timelines.
• Navigates and works effectively across multiple quality management systems, regulatory processes, and regional requirements to ensure timely execution of registrations
• Ensures submission tasks related to Change Control are completed
• Compiles and communicates Regulatory impact assessments, submission & approval status world-wide to Supply Chain to ensure regulatory compliance and business continuity
• Obtains Regulatory Certificates such as CFGs and FSCs
• Generate and coordinate responses to regulatory authority questions and deficiency letters in collaboration with internal subject matter experts.
• Support global product lifecycle activities, including renewals, labeling updates, and change assessments, ensuring ongoing compliance in assigned markets.

Education and Experience:

• Required Education and Experience
  • Bachelor's degree in health science, life science, biology, chemistry, bio-engineering, microbiology, or a related field.
  • Minimum 6 years of experience in the medical device industry
  • Experience with international regulatory product registrations and assessments across multiple regions, such as CASAJ, Greater China, LATAM, Canada, and EMEA.
  • Working knowledge of STED, technical files, design dossiers, and required submission structure and content.
  • Digital literacy with regulatory, quality, and business systems/tools such as SAP, Master Control, JDE, and Microsoft tools.
  • Microsoft Office Proficiency( AI Copilot, Agent, Word, Excel, PowerPoint, Power Bi)
  • Experience navigating Design History File (DHF) and reviewing Design Verification reports to support regulatory assessments, registrations, submissions, or product changes

• Technical Expertise
  • Maintained regulatory documentation, records, and tracking systems.
  • Evaluated product changes, post-market impacts, and regulatory risks to support market access.
  • Prepared regulatory submissions, assessed requirements, and ensured compliance…