Director, Regulatory Affairs - Compliance Systems and Labeling
Terumo BCTLakewood, Colorado, United States
Posted December 18, 2025
196500 - 245600 USD year
Full Time
About the Company
Terumo Blood and Cell Technologies is a medical device company that manufactures devices, disposable sets and solutions at facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam.
Job Description
Director of Regulatory Affairs – Compliance Systems and Labeling responsible for directing regulatory and labeling activities for Terumo Blood and Cell Technologies and collaborating with senior teams to define strategy and compliance programs.
Requirements
- Four-year college degree required and an advanced degree in the physical sciences considered a plus.
- Professional education in Regulatory Sciences desired with regulatory certification a plus.
- Minimum of 10 years regulatory experience with increasing responsibility in the medical device or pharmaceutical industry.
- Experience with both sterile disposables and electro-mechanical medical devices with embedded software preferred.
- Knowledge of the software in medical device regulations preferred.
- Experience with pharmaceutical submissions (NDA/ANDA in eCTD format) or medical device submissions (510(k), PMA, CE mark, etc.).
- Minimum 5 years managerial experience with multiple direct reports.
- A demonstrated track record of representing unique technologies to regulatory authorities and gaining timely approvals is critical.
- Experience working closely with clinical experts in all stages of clinical trials.
- Experience in regulatory compliance requirements desired (Health Hazard Evaluations, Removals and Corrections, Adverse Event Reporting, Promotional Material review, etc.).
- Direct experience in and knowledge of business and management principles involved in tactical execution, strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
- Experience working in Quality or leading a Quality team is preferred.
Benefits
- Multiple group medical, dental and vision plans
- Robust wellness program
- Life insurance and disability coverages
- Voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and more
- 401(k) plan with a matching contribution
- Vacation and sick time programs for associates