We are the people who give possibilities purpose

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.

Job Description

The Specialist, Medical Affairs for Post-Market Surveillance (SMA-PMS) for Specimen Management (SM), Medical Affairs (SA) is responsible for post-market reporting compliance activities. This position is accountable for coordinating and contributing to the SM post market surveillance reports and ensuring alignment with US, EU, Canada and other regional/country regulations through the implementation of an efficient and effective post-market reporting process. This position is also responsible for assisting in the management and maintenance of proactive customer quality response activities for MA for SM products.

The SMA-PMS demonstrates understanding of technical/scientific principles applicable to in vitro diagnostics and those of associated disciplines (such as R&D, Regulatory Affairs, Quality Assurance, or Project Management). The Specialist, Medical Affairs represents the interest of the patient and the health care worker and has basic understanding of patient safety and product safety and risk assessment. 

The SMA-PMS has working knowledge of international regulations and BD policies and procedures and moderate knowledge of and familiarity with BD products, product development process, ISO standards, FDA regulations, and IVD-R.

Duties and Responsibilities:

• Works with manager to understand full needs of Medical Affairs (MA) function as it relates to Post Market Surveillance (PMS) Program and annual Post Market Surveillance activities (PMS Plan and Periodic Safety Update Report, PSUR) for Specimen Management (SM) MA, SM products (Laboratory Specimen Management, Specimen Acquisition & Emerging Specimen Management).

• Understands the methodologies required for ongoing post market surveillance

• Implements processes for acquiring, managing, analyzing, interpreting, and reporting Post Market Surveillance data necessary to support PMS reports and PSURs as directed by manager

• Coordinates with QA/RA departments to facilitate completion of PMS and PSUR reports for each product family

• Supports Safety/Risk management activities and updates Health Risk Assessments and Benefit Risk Assessments for SM products. Duties may extend to MA representation for Situation Analysis and Health Risk Analysis deliverables

• Conducts literature search reviews for specified products, and reviews and screens resulting scientific papers for inclusion

• Maintains and updates SM MA Summary of Safety & Performance

• Duties may extend to supporting MDR/IVDR Technical File deliverables for new products

• Creates coherent, professional documentation and correspondence of moderate complexity. Is able to draw conclusions from primary and other written and/or verbal sources, present, and/or act on them effectively.  Is effective when speaking among peers, team members and functional or Business Management.  Work product may require limited review by managers from technical or stylistic point of view.

• Recognizes potential problems and takes preventive steps.  Recommends solutions for more complicated or ambiguous issues for consideration. 

• Manages multiple projects with ability to organize and prioritize assignments and effectively manages multiple tasks as assigned.

• Manages most activities without supervision.  Interactions with management involve weekly or more frequent updates on activities, discussion of issues, proposals for resolution.

• Reviews work for accuracy and follows up with cross functional data owners for clarification as required

• Ensures that accurate, high-quality reports are compiled and reviewed in a timely manner per project timelines and workload demands, and are in compliance with regulatory requirements

• Asserts own ideas and persuades others.  Fosters collaboration among team members.

• Serves as central SM MA contact for HCP contracting process in BD internal compliance system (such as Interactions Hub)

• Serves as central SM MA contact for post-market study requests management in CyberGrants portal for external funds (ISS and CRA).

Minimum Requirements

• Bachelor's degree in biomedical sciences, life sciences, clinical, laboratory, or other relevant technical areas
• Minimum 1 year of experience in Quality, Medical Affairs, Clinical research in microbiology or molecular biology, biomedical librarian, or related discipline
• Excellent writing skills and demonstrated accuracy in documentation/record-keeping practices
• Strong inter-department coordination skills
• Time management and activity management capabilities
• Familiarity with in vitro diagnostics in a clinical or academic setting
• Knowledge of medical/technical terminology
• Strong critical thinking, strategic assessment, and analytical problem-solving skills
• Excellent verbal and written communications skills
• Professionalism and interpersonal skills
• Ability to deal with ambiguity

Preferred Qualifications

• PhD would be a plus
• Technical or scientific writing experience or publication history
• Knowledge, understanding, and interpretation of FDA regulations, ISO standards, EU MDR/IVDR, and other industry standards for medical devices as they apply to PMS reporting
• Working knowledge of Quality Assurance, Regulatory, or Quality compliance activities in a medical device or similar industry
• Familiarity with BD products
• Professional certification (type not specified, but likely relevant to medical affairs or quality assurance)

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.

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 

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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.

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At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

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