Regulatory Affairs Manager Biomaterials & External Innovation

Brighter Signals; West Chester (Chester County); Sur place; USD 117 000 - 201 000; Plein temps

Résumé du poste

Johnson & Johnson’s Orthopaedics group seeks a Manager, Regulatory Affairs – Biomaterials External Innovation to drive regulatory strategies for biomaterials, biologics and externally sourced innovations. You will partner across R&D, Quality, Clinical and Commercial to guide submissions and lifecycle activities.

The role emphasizes CMC/CGMP compliance, BLA/IDE experience, and leadership of cross‑functional teams to enable timely global approvals and market readiness.

Qualifications

• Bachelor’s degree in a scientific, engineering, pharmacy or related field.
• 8+ years of regulatory experience in medical devices, biologics or related areas.
• Demonstrated expertise in CMC, CGMP and regulatory submissions (BLA/IDE).

Responsabilités

• Lead regulatory activities for biomaterials, biologics and combination products.
• Develop and execute regulatory strategies for external innovation opportunities.
• Prepare regulatory submissions and maintain regulatory files (BLAs, IDEs, PMAs, 510(k)s).
• Coach cross-functional teams and partners on regulatory requirements and risks.
• Engage with global/regional authorities to align strategy and timing.

Connaissances

Regulatory strategy

Leadership

Cross-functional collaboration

CMC

CGMP

Formation

Bachelor’s degree

Advanced degree preferred

Outils

BLA

IDE

PMA

510(k)

Description du poste

Johnson & Johnson’s Orthopaedics group seeks a Manager, Regulatory Affairs – Biomaterials External Innovation to drive regulatory strategies for biomaterials, biologics and externally sourced innovations. You will partner across R&D, Quality, Clinical and Commercial to guide submissions and lifecycle activities.

The role emphasizes CMC/CGMP compliance, BLA/IDE experience, and leadership of cross‑functional teams to enable timely global approvals and market readiness.