Senior Regulatory Affairs Specialist — Remote (Medical Devices)

VB Spine, LLC; Allendale (NJ); On-site; USD 100,000 - 105,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off

Professional development

Growth opportunities

Job summary

VB Spine is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies for spinal products in US, EU, and global markets. This role involves coordinating with FDA and international authorities, authoring submissions, and ensuring ongoing regulatory compliance.

The position requires 2+ years in regulatory affairs for FDA-regulated medical devices, a scientific bachelor’s degree, and strong communication skills. Remote work is available with travel up to 10% as needed.

Qualifications

• Bachelor’s degree in a scientific field; RAC certification desired.
• Minimum 2+ years in Regulatory Affairs within FDA-regulated medical devices.
• Experience preparing 510(k)s and/or Technical Documentation (required).
• Knowledge of US and EU medical device regulations (international a plus).
• Strong communication and organizational skills.
• Ability to lead projects and collaborate in cross-functional teams.

Responsibilities

• Participate on cross-functional product development teams to ensure regulatory requirements are incorporated across US, EU, and international markets.
• Author and manage regulatory submissions (510(k)s and Technical Documentation).
• Communicate FDA feedback to project teams and leadership.
• Support post-market submissions and annual reports.
• Conduct regulatory assessments for product changes and transfers.
• Advise teams on regulatory pathways to market.
• Interface with FDA and other authorities on submissions and compliance.
• Review ECNs, labeling, and IFUs for regulatory compliance.
• Maintain regulatory information systems and CE/Design Dossiers.
• Support audits and inspection readiness activities.
• Develop and maintain Regulatory Affairs SOPs and processes.
• Provide guidance to junior staff.

Skills

Regulatory affairs

Project management

Communication skills

Team leadership

FDA/Regulatory knowledge

Education

Bachelor’s degree in scientific field

RAC certification desirable

Tools

Microsoft Office

Job description

VB Spine is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies for spinal products in US, EU, and global markets. This role involves coordinating with FDA and international authorities, authoring submissions, and ensuring ongoing regulatory compliance.

The position requires 2+ years in regulatory affairs for FDA-regulated medical devices, a scientific bachelor’s degree, and strong communication skills. Remote work is available with travel up to 10% as needed.