The role involves developing and leading global regulatory strategies while mentoring the team on local and international regulations. You will also manage regulatory submissions, oversee post-market changes, and ensure compliance across clinical and manufacturing processes.
What You’ll Do:
Train and mentor the Regulatory Affairs team on sources, resources, and the status of local, regional, and global regulations
Actively participate as a project stakeholder, driving value and meeting planned milestones
Develop, update, and lead global regulatory strategies and Regulatory Plans for projects
Prepare, submit, and track regulatory applications under review; provide updates to project teams independently
Negotiate with regulatory authorities on common issues throughout the submission process
Perform and oversee regulatory impact assessments of post-market changes
Act as an independent reviewer for peer submissions
Support global registration activities by providing data, developing documentation, and coordinating information requests
Monitor the regulatory environment and share relevant updates with the broader RA team
Review and approve collateral materials, Medical Education materials, and presentations
Actively participate in and support external audits
Execute acquisition integration strategy post-close under limited supervision
Drive process improvements and recommend changes to procedures
Advise on regulatory requirements for quality, preclinical, and clinical data in support of submissions and clinical study applications
Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies
Ensure compliance with post-approval/clearance requirements, labeling, advertising, and promotional materials
What You Bring:
Bachelor’s degree (B.A. or B.S.) in Science, Legal, Regulatory, Engineering, or equivalent
RAC certification preferred
Minimum of 7 years of regulatory experience in the medical device or pharmaceutical industry
Demonstrated knowledge and skills in regulatory pathways, risk-benefit analysis, submissions, registration, compliance, post-market surveillance, and distribution
Ability to operate with appreciable latitude for independent action and decision-making
Experience planning, conducting, and overseeing regulatory assignments with limited supervision
Strong communication, collaboration, and stakeholder management skills
Ability to mentor and potentially oversee the work of Specialists or Senior Specialists
Willingness to accept challenging assignments that stretch and build capabilities
Why VB Spine? We believe in growing talent from within. At VB Spine, join a high-performing Regulatory Affairs team where you’ll provide senior-level strategic guidance that enables the successful global launch and continued compliance of innovative spinal technologies.
Compensation: Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $135,000.00 - $145,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, regulatory expertise, and market conditions.
Benefits include:
Comprehensive health, dental, and vision insurance
401(k) with company match
Paid time off (PTO) and holidays
Ongoing training and professional development opportunities
Opportunity to grow within a fast-paced, dynamic company
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