Manager, Regulatory Affairs


Location: Leesburg, VA (hybrid)
Company: VB Spine

Looking to advance your career in regulatory strategy while directly impacting patient outcomes? At VB Spine, you’ll contribute to life-changing spinal innovation and ensure breakthrough technologies reach surgeons and patients safely and efficiently. We are seeking a Regulatory Affairs Manager to lead regulatory execution and compliance for a diverse portfolio of spinal implants and instrumentation.

In this role, you will drive global regulatory strategy, manage submissions, ensure compliance with U.S. and EU regulations, and collaborate with cross-functional partners to support product development, market expansion, and business growth.

What You’ll Do

  • Develop and execute U.S. and EU regulatory strategies for new and existing product lines

  • Serve as the RA representative on product development teams, ensuring regulatory requirements are incorporated throughout the lifecycle

  • Prepare regulatory submissions including 510(k)s, IDEs, PMAs (originals/supplements), Technical Files, and Design Dossiers

  • Interface with regulatory bodies including FDA, Notified Bodies, and Competent Authorities to secure approvals and resolve issues

  • Review and approve labeling, marketing content, and promotional materials for compliance

  • Provide regulatory assessments supporting product changes, transfers, and market access decisions

  • Interpret evolving regulatory requirements and implement compliant processes and SOPs

  • Develop and maintain regulatory information systems and product listings/registrations

  • Communicate regulatory updates to internal stakeholders and leadership

  • Conduct RA and Quality training, ensuring organizational readiness and compliance

  • Manage and mentor regulatory staff members as required

What You Bring

  • Bachelor’s Degree in Science, Legal, Regulatory, or Engineering discipline (RAC certification highly preferred)

  • 4–5+ years of regulatory experience in FDA and EU regulated medical devices

  • Hands-on experience preparing FDA submissions (510(k), IDE, PMA) and EU Technical Files/Design Dossiers

  • Strong knowledge of U.S. and European medical device regulations and pathways to market

  • Direct experience interacting with regulatory authorities and inspectors

  • Excellent communication skills with the ability to influence and collaborate cross-functionally

  • Highly organized with strong analytical and problem-solving abilities

  • Proficiency with desktop software systems and electronic regulatory documentation

  • Quality Assurance experience a plus

Why VB Spine?

We believe in growing talent from within. At VB Spine, you’ll join a high-performing team, benefit from peer and executive mentorship, and influence strategy in the dynamic field of medical devices—positioning yourself to impact growth and innovation 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 $145,000 - $165,000 annually, plus bonus potential and a comprehensive benefits package. 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-driven company

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