Director, Regulatory Affairs – MedTech & Devices

Johnson & Johnson MedTech; Florida; On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson MedTech is seeking a Director, Regulatory Affairs to lead regulatory strategy across orthopaedics devices. This role will manage global submissions, coordinate cross-functional teams, and ensure on-time regulatory clearance in key markets.

The ideal candidate has extensive regulatory leadership experience, a strong track record with medical devices, and the ability to mentor regulatory staff during product lifecycles.

Qualifications

• Bachelor's degree in technical field required; advanced degrees preferred.
• Minimum 10 years in regulated industry with regulatory leadership experience.
• Proven track record in developing and executing global regulatory strategies.

Responsibilities

• Set regulatory strategy and lead global submissions across markets.
• Direct Regulatory Staff and ensure timely product clearances.
• Collaborate with R&D, Quality, and other functions on regulatory plans.
• Monitor global regulatory environment and advise management.
• Lead training initiatives on regulatory requirements across teams.
• Establish communications with global/regional regulatory agencies.

Skills

Regulatory leadership

Global regulatory strategy

Cross-functional collaboration

Strategic thinking

Education

Bachelor's degree in a technical field

MS/ME/PhD or MD preferred

Job description

Johnson & Johnson MedTech is seeking a Director, Regulatory Affairs to lead regulatory strategy across orthopaedics devices. This role will manage global submissions, coordinate cross-functional teams, and ensure on-time regulatory clearance in key markets.

The ideal candidate has extensive regulatory leadership experience, a strong track record with medical devices, and the ability to mentor regulatory staff during product lifecycles.