Sr. Staff Regulatory Affairs Specialist
About The Position
VB Spine is seeking a highly experienced Sr. Staff Regulatory Affairs Specialist to join their high-performing Regulatory Affairs team. This role will provide senior-level strategic guidance to enable the successful global launch and continued compliance of innovative spinal technologies. The specialist will train and mentor the Regulatory Affairs team, act as a project stakeholder, develop global regulatory strategies, prepare and submit regulatory applications, negotiate with regulatory authorities, and perform regulatory impact assessments. This position requires a high degree of autonomy and decision-making, with the ability to mentor junior team members.
Requirements
- Bachelor’s degree (B.A. or B.S.) in Science, Legal, Regulatory, Engineering, or equivalent
- Minimum of 7 years of regulatory experience in the medical device or pharmaceutical industry
- Demonstrated knowledge and skills in regulatory pathways, risk-benefit analysis, submissions, registration, compliance, post-market surveillance, and distribution
- Ability to operate with appreciable latitude for independent action and decision-making
- Experience planning, conducting, and overseeing regulatory assignments with limited supervision
- Strong communication, collaboration, and stakeholder management skills
- Ability to mentor and potentially oversee the work of Specialists or Senior Specialists
- Willingness to accept challenging assignments that stretch and build capabilities
Nice To Haves
- RAC certification preferred
Responsibilities
- Train and mentor the Regulatory Affairs team on sources, resources, and the status of local, regional, and global regulations
- Actively participate as a project stakeholder, driving value and meeting planned milestones
- Develop, update, and lead global regulatory strategies and Regulatory Plans for projects
- Prepare, submit, and track regulatory applications under review; provide updates to project teams independently
- Negotiate with regulatory authorities on common issues throughout the submission process
- Perform and oversee regulatory impact assessments of post-market changes
- Act as an independent reviewer for peer submissions
- Support global registration activities by providing data, developing documentation, and coordinating information requests
- Monitor the regulatory environment and share relevant updates with the broader RA team
- Review and approve collateral materials, Medical Education materials, and presentations
- Actively participate in and support external audits
- Execute acquisition integration strategy post-close under limited supervision
- Drive process improvements and recommend changes to procedures
- Advise on regulatory requirements for quality, preclinical, and clinical data in support of submissions and clinical study applications
- Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies
- Ensure compliance with post-approval/clearance requirements, labeling, advertising, and promotional materials
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
- Potential for bonuses and incentives
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What This Job Offers
Job Type
Full-time
Career Level
Senior
