Senior Regulatory Affairs Lead – Medical Devices (Remote)

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

Benefits offered by this job

Bonuses and incentives

Comprehensive health, dental, and vis​

Job summary

VB Spine is seeking a Sr. Staff Regulatory Affairs Specialist to lead regulatory efforts across global product development and lifecycle activities.

Located in Allendale, NJ, Leesburg, VA, or remote, this role drives regulatory strategy and submission initiatives in a fast-paced medical device environment. The candidate will mentor the RA team, coordinate with cross-functional partners, and ensure compliance with post-market and labeling requirements while supporting audits and integration

Qualifications

• Bachelor’s degree in Science, Legal, Regulatory, or Engineering.
• Minimum of 7 years regulatory experience in the medical device or pharmaceutical industry.
• Knowledge of regulatory pathways, risk-benefit analysis, submissions, registration, compliance, post-market surveillance, and distribution.
• Ability to operate with latitude for independent action and decision-making.
• Strong communication, collaboration, and stakeholder management skills.

Responsibilities

• Train and mentor the Regulatory Affairs team on local, regional, and global regulations.
• Actively participate as a project stakeholder, driving value and milestones.
• Develop, update, and lead global regulatory strategies and regulatory plans.
• Prepare, submit, and track regulatory applications with updates to project teams.
• Negotiate with regulatory authorities on common issues throughout submission.
• Oversee regulatory impact assessments of post-market changes.
• Support global registration activities by providing data and coordinating information requests.
• Monitor the regulatory environment and share updates with the RA team.
• Review and approve collateral materials, Medical Education materials, and presentations.
• Support external audits and acquisition integration post-close.

Skills

Regulatory strategy

Mentoring/leadership

Regulatory submissions

Stakeholder management

Independent decision-making

Education

Bachelor’s degree in Science/Regulatory/Engineering

RAC certification preferred

Job description

VB Spine is seeking a Sr. Staff Regulatory Affairs Specialist to lead regulatory efforts across global product development and lifecycle activities.

Located in Allendale, NJ, Leesburg, VA, or remote, this role drives regulatory strategy and submission initiatives in a fast-paced medical device environment. The candidate will mentor the RA team, coordinate with cross-functional partners, and ensure compliance with post-market and labeling requirements while supporting audits and integration