VP, Regulatory Strategy — Radiology Medical Devices

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

Job summary

Bayer in the United States, Pennsylvania (Indianola) seeks a Vice President, Head of Regulatory Affairs for Medical Devices in Radiology. You will lead regulatory strategy, global submissions (FDA 510(k)) and oversee a team of strategists and labeling experts to optimize development and lifecycle management.

The ideal candidate brings deep device regulatory knowledge, cross‑functional leadership, and strong authority with health agencies.

Qualifications

• Bachelor’s degree in regulatory or scientific field.
• Deep regulatory expertise in medical device regulations (FDA/EU).
• Proven track record of successful approvals in device areas.

Responsibilities

• Provide regulatory leadership for Medical Devices in Radiology.
• Oversee regulatory strategy, submissions (FDA 510(k)) and lifecycle management.
• Lead and coach Global Regulatory Strategists and Labeling Strategists.
• Collaborate with R&D, QA, and global health authorities.

Skills

Regulatory leadership

Regulatory strategy

Global regulatory experience

Team leadership

Communications skills

Education

Bachelor’s degree

Ph.D., M.D., P.Eng. or PharmD Regulatory device experience; or Master’s with Regulatory device experience and managerial experience

Job description

Bayer in the United States, Pennsylvania (Indianola) seeks a Vice President, Head of Regulatory Affairs for Medical Devices in Radiology. You will lead regulatory strategy, global submissions (FDA 510(k)) and oversee a team of strategists and labeling experts to optimize development and lifecycle management.

The ideal candidate brings deep device regulatory knowledge, cross‑functional leadership, and strong authority with health agencies.