Sr. Regulatory Affairs Specialist
VB Spine, LLC•Allendale, NJ
•$100,000 - $105,000
About The Position
VB Spine is seeking a Sr. Regulatory Affairs Specialist to join their high-performing team. This role will play a significant part in bringing innovative spinal technologies to market while ensuring full regulatory compliance. The position offers opportunities for continued growth in a dynamic, mission-driven medical device company.
Requirements
- 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
- Proficiency with personal computer systems and desktop office applications
- Sound understanding of scientific and regulatory principles
Nice To Haves
- RAC certification desired
- international experience a plus
- Bachelor’s degree (B.S. or B.A.) in a scientific area preferred
- 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
Responsibilities
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
