[Hiring] Senior Staff Regulatory Affairs Specialist @VB Spine, LLC

Role Description

• 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

Qualifications

• Bachelor’s degree (B.A. or B.S.) in Science, Legal, Regulatory, Engineering, or equivalent
• RAC certification preferred
• 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

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