Sr. Staff Regulatory Affairs Specialist

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
• Define and lead global regulatory strategy and the creation of Regulatory Plans for projects under limited supervision
• Prepare, submit, and track regulatory applications under review and provide updates to project teams independently
• Negotiate with regulatory authorities on common issues throughout the submission process
• Act as an independent reviewer for peer submissions
• Perform and oversee regulatory impact assessments of post-market changes
• Support global registration activities by providing data, developing documentation, and coordinating 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
• Evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure compliance
• Anticipate regulatory obstacles and emerging issues and develop solutions
• Lead SOP development and review
• Provide regulatory strategy and input to new product development and product lifecycle planning
• Evaluate regulatory impact of proposed changes to launched products
• Ensure compliance with post-approval/clearance requirements, labeling, advertising, and promotional materials
• Compile, prepare, review, and submit regulatory dossiers to authorities

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
• Strong technical and management skills engaged in regulatory strategy and operations
• Demonstrated knowledge of 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
• Ability to mentor and potentially oversee the work of Specialists or Senior Specialists
• Strong communication, collaboration, and problem-solving skills
• 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