Medical Affairs Manager

Becton Dickinson Medical Devices•San Diego, CA

2d•Hybrid

About The Position

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. Medical Affairs is responsible for ensuring the safety and efficacy of Medication Delivery Solutions (MDS) products worldwide. The Medical Specialist, MDS will support this mission by supporting the work required for EU MDR and providing the clinical users’ perspective for new product development and changes / enhancements to current products. (Summary) Key responsibilities will include:

Requirements

Minimum of a bachelor’s degree in health-related field (Registered Nurse, Nurse Practitioner, MD, DO) required.
At least of 5 years of clinical practice required
Excellent interpersonal skills and ability to collaborate with cross-functional teams
High degree of critical thinking skills
Excellent organizational skills
Strong written and verbal communication skills
Proficiency with MS Office applications
Ability to travel 10-15% of time

Nice To Haves

Previous medical device or pharmaceutical industry experience preferred
Knowledge of international medical device regulations preferred

Responsibilities

Collaborates with the sustaining cross-functional and new product development teams to serve as the MDS representative to provide guidance on: Summary of Technical Documentation (STeD) Intended purpose, patient population, and intended user Measurable clinical benefits including indirect clinical benefits Measurable clinical safety and performance objectives IFUs and labeling to ensure required content has been included Clinical evidence strategy Summary of Safety and Clinical Performance Reports
Collaborates with the Clinical Evaluation Report Medical Writers to provide: Education on the medical device under review Medical device alternatives Guidance on literature search protocols Guidance on external database searches
Collaborates and provides guidance with Quality and BU MA on off-label use or risks not found in risk management Feedback on the Clinical Evaluation Plan and Clinical Evaluation report
Collaborates with Quality to provide input into the Post-Market Surveillance Plan and required Post-Market Surveillance Reports Post Market Clinical Follow-up (PMCF) Writes PMCF Plans Provides support for the execution of the required PMCF activities Collaborates with 3rd party vendors to create PMCF surveys Writes PMCF Reports
Collaborates and provides guidance with Quality and BU MA on off-label use or risks not found in risk management
Responds to the Notified Body clinical queries
Responds to internal and external audits
Continuously develops knowledge of regulatory requirements in alignment with BD Practice Standards
Onboards new associates
Other responsibilities as supported by management