Job Description Summary

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.

• Lead the development and writing of Clinical Evaluation Reports (CERs) in compliance with regulatory requirements and guidelines.
• Authors / provides input into Clinical Evaluation Reports (CER), Clinical Evaluation Plan (CEP, Post Market Clinical Follow-up Plan (PMCFp), and Post Market Clinical Follow-up Report (PMCFr).
• Organize and lead projects needed to ensure compliance with MDD and the new MDR regulation and an efficient response from the business, regulatory and evidence generating functions.
• Coordinate and lead efforts to develop and maintain reports and data sets (including Clinical Evaluation Report and Risk Management Documentation deliverables), to support adherence to international regulations and reporting requirements.
• Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical operations, to gather and interpret clinical data.
• Serve as the subject matter expert to support the EU MEDDEV/MDR program for the medical & scientific content of internal product documentation and regulatory submissions for new products and for renewals.
• Partner globally with and provide strategic input to Medical & Regulatory Affairs teams for clinical activities for the MEDDEV/MDR program and evidence generation needs.
• Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, Marketing to ensure accurate and appropriate input into the Clinical Evaluation Report sections.
• Drive post-market surveillance (PMS) activities by leading systematic literature reviews (e.g., screens articles against inclusion / exclusion criteria, interpreting study results, synthesizing literature and preparing reports) for Infusion device / system products.
• Ensure the Clinical Evaluation Report documents are written in accordance with BD procedures, internal and external guidelines and applicable regulations.
• Perform MAUDE database searches and reviews and summarizes content.
• Author and drive the generation of Risk/Benefit Analyses, Known Use Error Reports or other relevant Medical Affairs documents required for regulatory deliverables.
• Participates in cross-functional team support for FDA 510(k) submissions as needed, internal or external audits, or other such activities for Regulatory compliance and Quality Assurance efforts, as directed by management.
• Exchange complex medical & scientific unbiased information with the healthcare community.
• Develop significant scientific relationships with Key Opinion Leaders (KOLs) and other disease experts.
• Provide medical/scientific presentations as needed to internal & external groups.
• Stay updated with the latest regulatory requirements and industry best practices related to medical writing and clinical evaluations.
• Performs other duties and assignments as required.

• Advanced degree (Ph.D., MD, or equivalent prefered) in a relevant scientific or medical field.

• Minimum of 8-10 years of experience in medical writing within the medical device industry, with a strong focus on clinical evaluation reports.
• Proven track record of successfully leading and managing the development of CERs for medical devices, preferably infusion products.
• In-depth knowledge of regulatory requirements and guidelines, including MDR, MEDDEV 2.7/1 Rev 4, and other relevant standards.
• Excellent written and verbal communication skills, with the ability to present complex clinical data clearly and concisely.
• Strong organizational skills and attention to detail, with the ability to manage multiple projects and deadlines.

• Experience with BD infusion products or similar medical devices.
• Familiarity with regulatory submission processes and requirements in major markets (e.g., EU MDR, TGA, FDA, EMA).
• Proficiency in using medical writing and document management software.
• Experience with infusion devices, informatics, and connected medical technology preferred. Prior clinical practice and experience with BD Alaris strongly preferred.
• Previous experience with creating medical strategy, developing teams, and implementing medical processes preferred.
• Experience in risk management, post market surveillance, cybersecurity, field action decisions and business development preferred.
• Experience in and or managing studies including literature reviews, study design and execution, and compliance monitoring.
• Experience in continuous improvement projects and project management required.
• Experience in medical writing, publishing, and presenting at professional conferences strongly preferred.
• Prior management experience preferred.

• Excellent verbal and written communication skills, including the ability to write medical documents, scientific papers, and present at professional conferences.
• Ability to exercise independent judgement and discretion within a broadly defined range of policies and practices.
• Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.
• Demonstrated organizational, planning, and project management skills, including action oriented, focused urgency and driving for results.
• Ability to be effective in complex projects with ambiguity and/or rapid change.
• Orientation for detailed work, with emphasis on accuracy and completeness.

• Able to travel 15-25%
• Position requires flexible working hours, including some nights and weekends, as needed for support of customer and business activities.