Sr. Staff Regulatory Affairs SpecialistLocation: Leesburg, VA, Allendale, NJ, or Remote
Company: VB Spine
What You'll Do:- 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
What You Bring:- 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
- 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
Compensation:Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $135,000.00 - $145,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, regulatory expertise, and market conditions.
Benefits include:- 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
