Medical Affairs Lead for Medical Devices

2 weeks ago


Indianola, Pennsylvania, United States Bayer Full time
Medical Device Operations Lead Job Description

Bayer is seeking a highly skilled Medical Device Operations Lead to join our team. As a key member of our Medical Affairs department, you will be responsible for providing global medical and scientific expertise regarding our product portfolio, including devices and digital solutions.

Key Responsibilities:
  • Lead the creation, support, and management of notified body-related medical affairs activities, including CERs, PMCF, PSURs, and other regulatory submissions.
  • Consolidate existing medical-scientific expertise and activities between global product experts, ensuring seamless collaboration and information exchange.
  • Identify evidence gaps and support publication planning, opinion leader development, and educational content creation with relevant product teams and stakeholders.
  • Improve dialogue, information exchange, and alignment between global, regional, and country teams.
  • Member and medical lead for device development projects and studies within Product Squads.
  • Co-develop educational materials and content for internal and external stakeholders, ensuring accurate and up-to-date information.
  • Ongoing lifecycle support for license to market, including risk assessments and health risk assessments as required.
  • Lead/support aspects of global projects, adapting product offerings to critical industry trends and competitive activity with support from senior MA medical device/SaMD leaders.
  • Contribute to the continued execution of medical affairs as an industry-leading organization.
Requirements:
  • Advanced degree with clinical experience or a bioscience/engineering degree with relevant experience in the medical device area.
  • Relevant experience with medical device development, including FDA, EU, ICH, and Notified Bodies guidelines, initiatives, and regulations.
  • Medical device experience supporting the creation of educational content, ability to support the development of studies, and build evidence generation plans.
  • Strong communication and interpersonal skills, with the ability to drive measurable outcomes with virtual teams.
  • Desire and ability to work in a fast-growing, agile business environment, with willingness to travel internationally to global meetings and congresses.
  • Good medical writing skills and ability to analyze safety data, with fluency in English, both written and spoken.
Preferred Qualifications:
  • Medical qualification as MD or equivalent (D.O., M.B.B.S, etc.), preferred.
  • 2-3+ years industry experience, with exposure to artificial intelligence/machine learning applications in Radiology a plus.

Bayer offers a competitive compensation package, including a salary range of $181,694 to $272,541, plus additional benefits such as health care, vision, dental, retirement, PTO, and sick leave. This posting will be available for application until at least #LI-US.


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