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, and define and lead global regulatory strategy. They will prepare, submit, and track regulatory applications, negotiate with regulatory authorities, and perform regulatory impact assessments. The role also involves supporting global registration activities, monitoring the regulatory environment, reviewing collateral and medical education materials, and supporting external audits. Additionally, the specialist will execute acquisition integration strategy, drive process improvements, provide internal regulatory advice, anticipate regulatory obstacles, lead SOP development, and ensure compliance with post-approval requirements.
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
- Strong technical and management skills engaged in regulatory strategy and operations
- Demonstrated knowledge of 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
- Ability to mentor and potentially oversee the work of Specialists or Senior Specialists
- Strong communication, collaboration, and problem-solving skills
- 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
- Define and lead global regulatory strategy and the creation of Regulatory Plans for projects under limited supervision
- Prepare, submit, and track regulatory applications under review and provide updates to project teams independently
- Negotiate with regulatory authorities on common issues throughout the submission process
- Act as an independent reviewer for peer submissions
- Perform and oversee regulatory impact assessments of post-market changes
- Support global registration activities by providing data, developing documentation, and coordinating 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
- Evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure compliance
- Anticipate regulatory obstacles and emerging issues and develop solutions
- Lead SOP development and review
- Provide regulatory strategy and input to new product development and product lifecycle planning
- Evaluate regulatory impact of proposed changes to launched products
- Ensure compliance with post-approval/clearance requirements, labeling, advertising, and promotional materials
- Compile, prepare, review, and submit regulatory dossiers to authorities
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
