Job Description Summary

BD is hiring for the exciting position of Specialist, Medical Affairs! Reporting into the International Infusion Medical Affairs Organization, this position has the responsibility to provide medical, scientific, technical, and customer-focused support. You will provide expert guidance from a medical perspective to new product development, sustaining development, risk management and regulatory processes, and be responsible for providing expert medical affairs knowledge to the wider cross functional team.

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.

• Provide input into Clinical Evaluation Reports (CER's) and Risk Benefit Analyses (RBA's) as required.
• Represent Medical Affairs in New Product Development and Sustaining Development Core Teams, ensuring the role is represented according to BD's product development process
• Ensure any products developed meet the needs of the customers
• Collaboration and approval of documentation required according to the Quality Management System (QMS) for products under development and products in the post-market stage
• Provide expert input into the development of clinically relevant clinical test protocols
• Provide input into go-to-market models with business group and commercial teams
• Develop scientific relationships with Key Opinion Leaders (KOL's) within the infusion area
• Coordinate, attend and contribute to selected scientific and medical congresses and webinars.
• Participate as needed to activities related to the BD post-market vigilance system. This will include, but not be limited to - participation in the formation of Situation Analyses; Health Risk Assessments and Incident Investigations
• Ensure relevant and appropriate responses to customer inquiries for relevant BD products.
• Direct the regular review of scientific literature in cooperation with marketing for key-products.
• Collaborate with marketing stakeholders to develop and approve customer-facing promotional/marketing material as required.
• Continuously maintain knowledge for the medical and commercial teams as to developments and trends in medical practices relevant to the business.
• Maintain up to date knowledge of regulatory and quality assurance requirements in alignment with BD Practice Standards.

• Professional clinical degree (Registered Nurse or equivalent qualification), with at least 3 years clinical experience. Undergraduate degree required.
• Related experience in the medical device industry, preferably gained with Alaris or CME infusion devices.
• Excellent English communication, both written and verbal.
• Experience of writing and reviewing technical and / or academic documentation
• Coordinates, priorities, and works effectively in a constantly changing environment, process-oriented and demonstrates a sense of urgency in completing deliverables through effective goal setting and a strong result orientation.
• High attention to detail and accuracy.
• Ability to understand complex technical concepts.
• Ability to travel, including internationally up to 50-60% of the time.