Regulatory Operations Leader – RIM, PIM & EUDAMED

BD; Franklin Lakes (NJ); On-site; USD 138,000 - 220,000; Full time

Benefits offered by this job

Medical coverage

Health Savings Accounts

Flexible Spending Accounts

Dental coverage

Vision coverage

Hospital Care Insurance

Critical Illness Insurance

Life and AD&D insurance

Short-term disability coverage

Long-term disability insurance

Long-term care with life insurance

BD 401(k) Plan

Well-being resources

Job summary

BD is seeking an experienced Regulatory Operations leader to own governance across RIM and PIM systems and to align regulatory data with business needs. You will drive DEO governance, EUDAMED readiness, and NoC processes, providing insights to Regulatory Affairs leadership.

The role requires extensive experience in regulatory systems, data governance, and cross-functional project management within the medical device sector.

Qualifications

• Bachelor's degree required in science/engineering or related.
• 8+ years in regulatory affairs/operations or related medical device functions.
• Experience with regulatory systems and data governance.

Responsibilities

• Lead regulatory operations and governance for RIM/PIM.
• Oversee DEO governance and regulatory data alignment.
• Drive EUDAMED implementation and NoC governance.
• Develop regulatory metrics, dashboards and KPIs.
• Lead cross-functional regulatory projects and process improvements.

Skills

Regulatory operations

Regulatory affairs

Cross-functional leadership

Process improvement

Digital transformation

Project management

Education

Bachelor's degree in Science/Engineering/Regulatory Affairs/Business

Master's degree (preferred)

Tools

RIM systems

PIM

EUDAMED

Job description

BD is seeking an experienced Regulatory Operations leader to own governance across RIM and PIM systems and to align regulatory data with business needs. You will drive DEO governance, EUDAMED readiness, and NoC processes, providing insights to Regulatory Affairs leadership.

The role requires extensive experience in regulatory systems, data governance, and cross-functional project management within the medical device sector.