Senior Regulatory Affairs Leader – Global Strategy

VB Spine; Allendale (NJ); On-site; USD 135,000 - 145,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) match

Paid time off

Job summary

VB Spine is seeking a Principal Regulatory Affairs Specialist to lead global regulatory strategies, manage cross‑functional teams, and oversee submissions for spinal device innovations. You will mentor colleagues, coordinate with clinical, quality, and product teams, and drive compliance across lifecycle stages.

The role requires extensive regulatory experience in medical devices, RAC preferred, and the ability to operate with significant independence.

Qualifications

• Bachelor’s degree in Science, Regulatory, Engineering, or equivalent.
• RAC certification preferred.
• Minimum of 7 years regulatory experience in medical device or pharmaceutical industry.
• Knowledge of regulatory pathways, submissions, compliance, and post‑market surveillance.
• Ability to operate with latitude for independent action and decision making.
• Experience planning and overseeing regulatory assignments with limited supervision.
• Strong communication, collaboration, and stakeholder management skills.
• Ability to mentor and oversee Specialists or Senior Specialists.

Responsibilities

• Train and mentor Regulatory Affairs team on local, regional, and global regulations.
• Act as project stakeholder, drive value and milestones.
• Develop, update, and lead global regulatory strategies and plans.
• Prepare, submit, and track regulatory applications; provide updates to teams.
• Negotiate with regulatory authorities throughout submissions.
• Oversee regulatory impact assessments of post‑market changes.
• Support global registration activities with data and documentation.
• Monitor regulatory environment and share updates with RA team.
• Review collateral materials, MEDICAL EDUCATION content, and presentations.
• Support external audits and acquisition integration post‑close.

Skills

Regulatory knowledge

Submissions & registrations

Risk–benefit analysis

Stakeholder management

Mentoring teammates

Independent decision making

Communication & collaboration

Regulatory strategy

Education

Bachelor’s degree in Science/Regulatory/Engineering

RAC certification preferred

Job description

VB Spine is seeking a Principal Regulatory Affairs Specialist to lead global regulatory strategies, manage cross‑functional teams, and oversee submissions for spinal device innovations. You will mentor colleagues, coordinate with clinical, quality, and product teams, and drive compliance across lifecycle stages.

The role requires extensive regulatory experience in medical devices, RAC preferred, and the ability to operate with significant independence.