Senior Regulatory Affairs Lead - Med Device (Remote)

VB Spine, LLC; New Jersey; Sur place; USD 100 000 - 105 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) with company match

PTO and holidays

Training and development

Growth opportunities

Résumé du poste

VB Spine, LLC is seeking a Senior Regulatory Affairs Specialist to lead global regulatory strategies for spinal products. You’ll collaborate with cross-functional teams from early development through market approvals, drafting 510(k)s and technical documentation for US, EU, and other markets.

You will communicate with FDA and other Health Authorities, guide post‑market submissions, and help ensure compliance across QA, engineering, and manufacturing. Remote work options with travel are available.

Qualifications

• Bachelor’s degree in science or related field; RAC preferred
• Minimum 2+ years in Regulatory Affairs within FDA-regulated medical devices
• Hands-on experience preparing and submitting 510(k)s and/or Technical Documentation
• Knowledge of US and EU medical device regulations; international experience a plus
• Strong communication, organization, and project management skills
• Ability to lead on projects and mentor teammates

Responsabilités

• Participate on cross-functional product teams to ensure regulatory requirements are embedded early
• Author and manage regulatory submissions (510(k)s, technical docs) to obtain approvals
• Communicate FDA and Health Authority feedback to teams and RA leadership
• Support post-market submissions and annual reports
• Assess regulatory impact of product and manufacturing changes

Connaissances

Regulatory Affairs

510(k) submissions

FDA regulations

EU medical device regs

Cross‑functional teamwork

Project management

Mentoring/Leadership

Regulatory documentation

Formation

B.S./B.A. in science

RAC certification (desired)

Outils

Regulatory information systems

ECN management

Documentation management tools

Description du poste

VB Spine, LLC is seeking a Senior Regulatory Affairs Specialist to lead global regulatory strategies for spinal products. You’ll collaborate with cross-functional teams from early development through market approvals, drafting 510(k)s and technical documentation for US, EU, and other markets.

You will communicate with FDA and other Health Authorities, guide post‑market submissions, and help ensure compliance across QA, engineering, and manufacturing. Remote work options with travel are available.