Senior Director, Global Regulatory Law - Orthopedics

Brighter Signals

West Chester (Chester County)

On-site

USD 178,000 - 307,000

Full time

5 days ago
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Benefits offered by this job

Vacation 120 hours
Sick time
Holiday pay
Parental Leave
Bereavement Leave
Caregiver Leave
Volunteer Leave
Military Spouse Time-Off

Job summary

Johnson & Johnson, a global leader in healthcare, seeks a Sr. Director, Regulatory Law for DePuy Synthes to guide regulatory strategy across orthopedic devices. You will partner with Regulatory Affairs, Quality, R&D, and Commercial teams to enable innovation, ensure compliance, and support global market access.

The role requires deep regulatory experience, high-level leadership, and the ability to manage complex submissions and inspections in a fast-paced environment.

Qualifications

  • Typically requires 12–14 years of progressive legal experience in regulatory law.
  • Strong knowledge of FDA regulations, PMA/510(k) pathways and EU MDR/IVDR.
  • Proven ability to influence senior leaders and manage cross-functional teams.

Responsibilities

  • Serve as senior legal advisor on US and global regulatory law for medical devices and technology.
  • Provide strategic counsel on regulatory submissions, clearances, post-market actions and recalls.
  • Collaborate with Regulatory Affairs, Quality, R&D and Commercial teams to shape regulatory strategy.

Skills

Regulatory law
FDA regulations
Cross-functional leadership
Legal advisory

Education

Juris Doctor (JD)
Bar admission (US jurisdiction)

Job description

Johnson & Johnson, a global leader in healthcare, seeks a Sr. Director, Regulatory Law for DePuy Synthes to guide regulatory strategy across orthopedic devices. You will partner with Regulatory Affairs, Quality, R&D, and Commercial teams to enable innovation, ensure compliance, and support global market access.

The role requires deep regulatory experience, high-level leadership, and the ability to manage complex submissions and inspections in a fast-paced environment.

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