Strategic Director, Regulatory Affairs – Orthopaedics

Brighter Signals; Raynham (MA); Sur place; USD 164 000 - 283 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a Director of Regulatory Affairs for its Orthopaedics team. Based in multiple U.S. locations including Raynham, MA, the role leads global regulatory strategy and launches, directs regulatory staff, and partners with R&D, Quality, and Supply Chain to ensure compliant product commercialization.

The position requires a minimum of 10 years in regulatory affairs, a technical Bachelor's, and strong leadership skills to drive strategic initiatives across markets.

Qualifications

• Minimum of a Bachelor's degree in a technical field; advanced degrees preferred.
• Minimum 10 years of relevant/regulatory industry experience required.
• Senior leadership experience with multi-level reporting is required.
• Demonstrated track record of global regulatory strategy development and execution.

Responsabilités

• Lead submission and approval activities with global regulatory agencies.
• Define strategic regulatory direction for pipeline development and global launches.
• Collaborate with R&D, Quality, Supply Chain, and Marketing on regulatory plans.
• Oversee regulatory submissions including 510(k), IDE/IDE Supplements, PMA/PMA Supplements, and more.
• Develop and mentor Regulatory staff to build future leaders.
• Monitor global regulatory environment and advise on impact of changes.

Connaissances

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Strategic thinking

Regulatory compliance

Leadership development

Industry analysis

Innovation

Collaboration

Formation

Bachelor's degree in a technical discipline

MS/ME/PhD or MD preferred

Description du poste

Johnson & Johnson is seeking a Director of Regulatory Affairs for its Orthopaedics team. Based in multiple U.S. locations including Raynham, MA, the role leads global regulatory strategy and launches, directs regulatory staff, and partners with R&D, Quality, and Supply Chain to ensure compliant product commercialization.

The position requires a minimum of 10 years in regulatory affairs, a technical Bachelor's, and strong leadership skills to drive strategic initiatives across markets.