Medical Affairs Manager

Role Overview

• Serve as the strategic medical voice within cross‑functional teams, shaping product development, lifecycle management, remediation initiatives, and global regulatory strategy to ensure clinical relevance and patient safety.
• Interpret, develop, and maintain clinical performance and safety reporting requirements in alignment with evolving global regulations, including EU MDR, and other regional standards.
• Support regulatory submissions and technical documentation, including but not limited to, providing medical review of labeling, intended use statements, target populations, clinical claims, risk‑benefit narratives, and safety‑related content.
• Support and/or contribute to global clinical evidence generation activities, including protocol development, study design input, real‑world evidence initiatives, and post‑market clinical follow‑up (PMCF) planning.
• Oversee the compliant dissemination of scientific, clinical, and medical information to internal stakeholders, healthcare professionals, and external partners, ensuring alignment with regulatory and industry standards.
• Review and approve promotional, educational, and training materials for scientific accuracy and compliance; support advisory boards, expert panels, and scientific engagement activities; and coordinate independent research or educational grant requests.
• Develop, maintain, and review risk management documentation, ensuring comprehensive identification of failure modes, clinical risks, and mitigation strategies throughout the product lifecycle.
• Participate in crisis‑management and field action teams, providing medical expertise during product quality events, safety investigations, and corrective or preventive actions.
• Respond to medical inquiries and provide scientifically sound, evidence‑based information regarding the company’s products, indications, and clinical data.
• Monitor and synthesize emerging scientific literature, clinical trends, and competitive intelligence, collaborating with marketing and R&D to inform strategy and messaging.
• Stay current with global regulatory, clinical, pharmacovigilance, and quality requirements, ensuring alignment with internal standards and supporting continuous organizational readiness.

Requirements

• RN, PharmD, or equivalent clinical education.
• Minimum of 5 years of clinical practice experience with strong patient‑care insight.
• At least 2 years of relevant experience in the medical device or pharmaceutical industry, ideally within clinical research or medical affairs.
• Demonstrated experience in medical affairs operations, including support for regulatory and compliance obligations.
• Working knowledge of clinical trial processes and Good Clinical Practice (GCP) standards.
• Proven ability to identify unmet clinical needs, assess product opportunities from a clinical and scientific perspective, and contribute to evidence‑based development strategies.
• Strong business acumen and critical‑thinking skills, with the ability to clearly communicate complex scientific and strategic concepts in both written and verbal formats.
• Highly organized and results‑oriented, with a track record of setting clear goals and driving timely execution.
• Ability to prioritize effectively and thrive in a dynamic, fast‑changing environment.
• Exceptional communication and presentation skills, including the ability to deliver scientific and medical content to diverse audiences; proficient with standard business and scientific software tools.
• Familiarity with safety reporting requirements for both medical devices and pharmaceuticals.
• Willingness and ability to travel domestically and internationally up to 20%.

Tech Stack

• Google Cloud Platform

Benefits

• Annual Bonus Potential
• Discretionary LTI Bonus Potential
• reimbursement of phone use
• 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