[Hiring] Senior Regulatory Affairs Specialist @VB Spine, LLC

Role Description

• Participate on cross-functional product development teams to ensure US, EU, and international regulatory requirements are incorporated from the earliest stages.
• Author and manage regulatory submissions (including 510(k)s and technical documentation) to secure and maintain product approvals.
• Communicate FDA and other Health Authority feedback/correspondence to project teams and RA leadership.
• Support post-market submissions, including progress reports and annual reports.
• Conduct regulatory assessments for proposed product changes, manufacturing changes, and product transfers.
• Advise teams on appropriate regulatory pathways to market.
• Interface and coordinate directly with the FDA and other regulatory agencies on submissions, approvals, and compliance issues.
• Review and approve Engineering Change Notices (ECNs), labeling, collateral materials, and Instructions for Use (IFUs).
• Maintain regulatory information systems, US product listings, and CE Mark Technical Files / Design Dossiers.
• Support internal and external audits and inspection readiness activities.
• Contribute to the development and maintenance of Regulatory Affairs SOPs and processes.
• Provide guidance and support to junior Regulatory Affairs Specialists and Associates.
• Participate in continuous improvement initiatives within the Regulatory Affairs department.

Qualifications

• Bachelor’s degree (B.S. or B.A.) in a scientific area preferred; RAC certification desired.
• Minimum 2+ years of experience in Regulatory Affairs within the FDA-regulated medical device industry.
• Hands-on experience preparing and submitting 510(k)s and/or Technical Documentation (required).
• Working knowledge of US and EU medical device regulations (international experience a plus).
• Strong interpersonal, written, and verbal communication skills.
• Excellent organizational, planning, and project management abilities.
• Ability to work effectively in a team environment and provide leadership on projects.
• Proficiency with personal computer systems and desktop office applications.
• Sound understanding of scientific and regulatory principles.

Benefits

• 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.