Director, Regulatory Affairs — Orthopaedics (Global Strategy)

Brighter Signals; Warsaw (IN); On-site; USD 164,000 - 283,000; Full time

Benefits offered by this job

Vacation 120h

Sick leave 40h

Holiday pay

Parental leave

Volunteer leave

Military spouse time-off

Job summary

Johnson & Johnson in the Orthopaedics space seeks a Director of Regulatory Affairs to guide global regulatory strategy and lead a cross-functional team. The role drives timely clearances for devices across multiple markets while shaping regulatory direction for pipeline development and launches.

The position requires a minimum of 10 years in regulated industries, senior leadership experience, and a strong track record of global regulatory strategy execution.

Qualifications

• Bachelor's degree in a technical discipline required; advanced degrees preferred.
• Demonstrated senior leadership experience; global regulatory strategy experience highly valued.
• Experience building regulatory strategy and leading cross-functional teams.

Responsibilities

• Set regulatory strategy and partner with cross-functional teams to drive product innovation and launches.
• Lead and develop Regulatory staff toward future leadership roles.
• Oversee regulatory submissions (510(k), IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, etc.).
• Define global regulatory direction for pipeline development and launch excellence.
• Collaborate with R&D, Quality, Supply Chain, and Marketing to align regulatory plans with business goals.
• Monitor global regulatory environments and advise on impact to programs.

Skills

Leadership experience

Regulatory strategy

Cross-functional collaboration

Strategic thinking

Regulatory knowledge

Education

Bachelor's degree in technical field

MS/ME/PhD/MD preferred

Job description

Johnson & Johnson in the Orthopaedics space seeks a Director of Regulatory Affairs to guide global regulatory strategy and lead a cross-functional team. The role drives timely clearances for devices across multiple markets while shaping regulatory direction for pipeline development and launches.

The position requires a minimum of 10 years in regulated industries, senior leadership experience, and a strong track record of global regulatory strategy execution.