Medical Affairs Manager

Role Overview

• 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 UK and other geographies by supporting clinical efforts
• Supports the work required for EU MDR and providing the clinical users’ perspective for new product development and changes/enhancements to current products
• 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)
• Provides education on the medical device under review
• Collaborates and provides guidance with Quality and BU MA on off-label use or risks not found in risk management
• Writes PMCF Plans and provides support for the execution of the required PMCF activities
• Collaborates with 3rd party vendors to create PMCF surveys
• Responds to the Notified Body clinical queries and internal/external audits

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
• Previous medical device or pharmaceutical industry experience preferred
• 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
• Ability to travel 10-15% of time

Benefits

• 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