Global Regulatory Submissions Lead

Terumo Blood and Cell Technologies; Lakewood (CO); Hybride; USD 161 000 - 201 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision coverage

401(k) with matching

Paid time off

Résumé du poste

Terumo Blood and Cell Technologies in Lakewood, Colorado, is seeking a Senior Manager, Regulatory Affairs to lead a high-performing team and shape global regulatory submission strategies for innovative medical technologies. You will guide filings to the FDA, Health Canada, and EU regulators, mentor staff, and partner with R&D, Quality, and Operations to accelerate market access.

The role requires a minimum of 10 years in Regulatory Affairs with 3 years in management, a Bachelor's in a relevant

Qualifications

• Bachelor's degree in physical/biological sciences or engineering; Master's in Regulatory Affairs or MBA preferred.
• Minimum 10 years in Regulatory Affairs and 3 years in regulatory management.
• RAC desirable; ability to lead inspections and manage cross-functional programs.

Responsabilités

• Develops and executes global regulatory submission strategies for medical technologies.
• Lead preparation and submission of regulatory filings to FDA, Health Canada, and EU regulators under EU MDR.
• Mentor regulatory professionals and lead cross-functional teams across R&D, Manufacturing, Quality, and Operations.
• Oversee regulatory inspections and interactions with regulatory authorities.
• Monitor regulatory changes and advise on implications for product strategy.

Connaissances

Regulatory leadership

Regulatory submissions

Global regulatory strategy

Cross-functional collaboration

Leadership

Project management

Communication

Financial acumen

Mentoring

Regulatory inspections

Formation

Bachelor's degree in physical/biological sciences or engineering

Master's in Regulatory Affairs or MBA

Outils

Regulatory software

Description du poste

Terumo Blood and Cell Technologies in Lakewood, Colorado, is seeking a Senior Manager, Regulatory Affairs to lead a high-performing team and shape global regulatory submission strategies for innovative medical technologies. You will guide filings to the FDA, Health Canada, and EU regulators, mentor staff, and partner with R&D, Quality, and Operations to accelerate market access.

The role requires a minimum of 10 years in Regulatory Affairs with 3 years in management, a Bachelor's in a relevant