BD

Medical Affairs Manager

BD

full-time

Posted on:

Location Type: Hybrid

Location: San Diego • California • New Jersey • United States

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Salary

💰 $124,700 - $205,800 per year

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical practicePMCF PlansSummary of Technical DocumentationEU MDRregulatory requirementsrisk managementclinical queriesPMCF activitiesmedical device regulations
Soft Skills
interpersonal skillscollaborationcritical thinkingorganizational skillswritten communicationverbal communication
Certifications
bachelor’s degree in health-related fieldRegistered NurseNurse PractitionerMDDO