Job Description Summary
The MDS Medical Affairs Manager collaborates with cross-functional teams (Regulatory, Quality, Marketing, Business Medical Affairs and R&D) within MDS to obtain and maintain regulatory requirements for CE marking in the European Union (EU) and other geographies by supporting clinical efforts.
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.
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
- 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
Education
- 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
- Previous medical device or pharmaceutical industry experience preferred
Knowledge And Skills
- Knowledge of international medical device regulations preferred
- 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
Work/Travel
- Ability to travel 10-15% of time
- Hybrid: Close to office location with requirement to be in office three times per week
Benefits
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
Health and Well-being Benefits
- Medical coverage
- Health Savings Accounts
- Flexible Spending Accounts
- Dental coverage
- Vision coverage
- Hospital Care Insurance
- Critical Illness Insurance
- Accidental Injury Insurance
- Life and AD&D insurance
- Short-term disability coverage
- Long-term disability insurance
- Long-term care with life insurance
Other Well-being Resources
- Anxiety management program
- Wellness incentives
- Sleep improvement program
- Diabetes management program
- Virtual physical therapy
- Emotional/mental health support programs
- Weight management programs
- Gastrointestinal health program
- Substance use management program
- Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
Retirement and Financial Well-being
- BD 401(k) Plan
- BD Deferred Compensation and Restoration Plan
- 529 College Savings Plan
- Financial counseling
- Baxter Credit Union (BCU)
- Daily Pay
- College financial aid and application guidance
Life Balance Programs
- Paid time off (PTO), including all required State leaves
- Educational assistance/tuition reimbursement
- MetLife Legal Plan
- Group auto and home insurance
- Pet insurance
- Commuter benefits
- Discounts on products and services
- Academic Achievement Scholarship
- Service Recognition Awards
- Employer matching donation
- Workplace accommodations
Other Life Balance Programs
- Adoption assistance
- Backup day care and eldercare
- Support for neurodivergent adults, children, and caregivers
- Caregiving assistance for elderly and special needs individuals
- Employee Assistance Program (EAP)
- Paid Parental Leave
- Support for fertility, birthing, postpartum, and age-related hormonal changes
Leave Programs
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
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.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Required Skills
Optional Skills
Primary Work Location
USA CA - San Diego Bldg A&B
Additional Locations
USA IL - Vernon Hills, USA NJ - Franklin Lakes
Work Shift
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$124,700.00 - $205,800.00 USD Annual
