Global VP, Regulatory Affairs – Medical Devices

Bayer; Indianola (PA); On-site; USD 273,000 - 409,000; Full time

Benefits offered by this job

Health care

Vision insurance

Dental insurance

Retirement plan

Paid time off

Sick leave

Job summary

Bayer in United States (Pennsylvania, Indianola) seeks a Vice President, Head of Regulatory Affairs for Medical Devices in Radiology. You will direct global regulatory strategy, manage submissions (FDA 510(k)), and lead a diverse team to secure timely approvals while aligning with Bayer’s commercial goals.

Ideal candidate has deep device regulations knowledge, leadership in agile environments, and a track record of successful regulatory outcomes across global markets.

Qualifications

• Bachelor’s degree in a scientific field with regulatory exposure.
• Deep understanding of medical device regulations and global development processes.
• Proven track record of successful approvals in device areas, including FDA 510(k).
• Experience engaging Health Authorities, Notified Bodies, and distributors.

Responsibilities

• Lead global regulatory strategy for Radiology Medical Device products.
• Coach and develop Global RA teams across R&D portfolios.
• Oversee regulatory submissions and lifecycle management to optimize approvals.
• Monitor regulatory trends and advise on opportunities and threats.
• Ensure alignment with business objectives and market access strategies.

Skills

Regulatory affairs

Medical device regulations

FDA 510(k)

Quality System Regulations

Regulatory strategy

Education

Bachelor’s degree in a scientific field

Ph.D./M.D./ PharmD or regulatory certification

Job description

Bayer in United States (Pennsylvania, Indianola) seeks a Vice President, Head of Regulatory Affairs for Medical Devices in Radiology. You will direct global regulatory strategy, manage submissions (FDA 510(k)), and lead a diverse team to secure timely approvals while aligning with Bayer’s commercial goals.

Ideal candidate has deep device regulations knowledge, leadership in agile environments, and a track record of successful regulatory outcomes across global markets.