Senior Staff Regulatory Affairs Specialist

Senior Staff Regulatory Affairs Specialist

Location: Remote
Company: VB Spine

Looking for a role where your regulatory expertise drives innovation in medical technology? At VB Spine, you’ll join a mission-driven team dedicated to supporting life-changing spinal procedures through compliant, cutting-edge solutions. We’re seeking an experienced regulatory professional ready to lead complex projects, shape global strategy, and mentor others in a dynamic, collaborative environment.

What You’ll Do:

• Develop and update global regulatory strategies for new product development and lifecycle management
• Prepare, submit, and track regulatory applications (FDA, Notified Bodies, etc.) with minimal supervision
• Evaluate post-market changes and assess regulatory impact to ensure ongoing compliance
• Advise cross-functional teams and leadership on regulatory requirements, risks, and strategies
• Monitor and interpret evolving regulatory landscapes across key markets
• Lead process improvements and contribute to inter-departmental and industry working groups
• Review and approve labeling, promotional materials, and public communications for compliance
• Support external audits and acquisition integration activities

What You Bring:

• Bachelor’s degree in Science, Legal, Regulatory, Engineering, or equivalent field
• Minimum of 6 years of regulatory experience in medical device or pharmaceutical industries
• RAC certification or advanced degree strongly preferred
• Strong knowledge of FDA, EU MDR, and other global regulatory frameworks
• Proven ability to lead complex projects, negotiate with authorities, and mentor team members
• Excellent analytical, communication, and strategic thinking skills

Why VB Spine?

We believe in growing talent from within. At VB Spine, you’ll join a high-impact team, benefit from peer and executive mentorship, and play a key role in shaping regulatory strategy—positioning yourself to influence innovation and compliance across the organization.

Compensation:
Pay for this role is competitive and based on experience, with additional factors like qualifications and performance taken into account. The typical pay range for this position is $135,000 – $145,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers experience level, skillset, 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, mission-focused company