JOB DESCRIPTION SUMMARY

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.

• Support the development and maintenance of Clinical Evaluation Plans/Reports, Post-market Clinical Follow-up Plans/Reports in compliance with applicable regulatory requirements (e.g. EU MDR, MDCG)
• Represent Clinical Affairs in cross-functional teams to support international product registrations and audits from EU Notified Bodies and Proficient Authorities
• Assist in planning and execution of pre- and post-market clinical strategies
• Develop Clinical Investigation Plans, Informed Consent Forms and other study-related documents
• Prepare study submission files and interact with Ethics Committees and Proficient Authorities
• Collaborate with various functions in the BD Clinical Affairs Team and external service providers (CROs, consultants)
• Site Management and regular interaction with clinical investigators and other site staff
• Assist with electronic Trial Master File (TMF) maintenance and the conduct of TMF audits
• Plan and implement efficient processes for device management and other study supplies
• Support the Post-Market-Surveillance process and related documentation