Job Description Summary

The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.
The Senior International Regulatory Affairs Specialist will execute regulatory project timelines and manage the processes and systems designed to ensure that all regulatory requirements are met for a location change (re-location) of a production facility and Legal Manufacturer address change.
The Senior International Regulatory Affairs Specialist will be responsible for partnering in the preparation and approval of regulatory submissions of medical devices worldwide.

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. 

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. 

• 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 

• Assists in developing, maintaining, regulatory strategies, reporting regulatory submission & approval status dashboard & metrics. 

• Obtains Regulatory Certificates such as CFGs, FSCs 

Education and Experience: 

• Bachelor's degree in health science or life science field (biology, chemistry, bio-engineering, microbiology) or related field. 

• Minimum 5-10 years’ experience in the device/diagnostic, biologic and/or pharmaceutical industry in regulatory affairs 

• Experience with several international countries RA product registration/assessment (CASAJ, Gr. China, LATAM, Canada, EMEA)  

• Proven ability to interpret medical device regulatory requirements, Good Laboratory Practices (GLP), and Quality System Regulations (QSR) 

• Lead, influence and apply feedback from cross functional teams (B2B, Regional and Country RA associates, MDS Business Platforms , and Regulatory bodies). 

• Digital literacy (SAP, Excel, Pivot Tables, PowerPoint, Access, Agile, Regulatory e-Systems) 

• Project management experience highly preferred; experience with prioritizing multiple tasks and driving results. 

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.

At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role: 

• Annual Bonus

• Potential Discretionary LTI Bonus

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Health and Well-being Benefits  

• Medical coverage  

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