Principal Clinical Regulatory Scientist
Location: Remote/Hybrid, Leesburg, VA or Allendale, NJ
Company: VB Spine
Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports life-changing spinal procedures. We’re looking for driven individuals ready to learn quickly, collaborate cross-functionally, and thrive in a dynamic, fast-paced environment.
As a Principal Clinical Regulatory Scientist, you’ll play a key role in establishing and leading the clinical evidence strategy for both new and existing medical devices. You’ll be responsible for planning, creating, and updating critical documentation, including Clinical Evaluation Plans and Reports (CEPs/CERs), Post-Market Clinical Follow-up (PMCF) documents, and Summary of Safety and Clinical Performance (SSCP) documents to support global market access.
In this role, you’ll assess compliance with internal and external safety and performance requirements by reviewing, analyzing, and concluding on clinical evidence. You’ll lead complex projects, engage with regulatory agencies, help shape departmental strategies, and provide valuable insights on evolving regulatory and clinical trends. Additionally, you’ll manage operational and regulatory deliverables and may need to defend them in audits.
What You’ll Do:
- Lead clinical evaluation strategy development and execution for new product development cycles and existing products.
- Ensure regulatory compliance and oversee clinical regulatory documentation (e.g., CERs, CEPs, PMCF Reports).
- Collaborate with cross-functional teams (Marketing, Regulatory, Clinical Affairs) for global regulatory submissions and product development.
- Perform systematic reviews of clinical literature and assess current trends in the clinical state of the art.
- Analyze post-market surveillance, marketing, and preclinical data to generate comprehensive scientific reviews.
- Drive benefit-risk assessments in collaboration with medical experts and stakeholders, based on global regulatory requirements.
- Identify knowledge gaps in clinical evidence and coordinate post-market follow-up activities.
- Represent clinical regulatory expertise in internal and external quality audits.
What You Bring:
- Minimum of a Master's or PhD in a health-related field (e.g., RN, BSN, BPharm, MD, MPH).
- 8+ years of experience in clinical, quality, or regulatory affairs, with at least 2-4 years focused on clinical evaluation in the medical device industry.
- Expertise in scientific or medical writing and academic or clinical research (PhD, Post-doc preferred).
- In-depth knowledge of global clinical evaluation regulations.
Strong ability to manage complex projects, providing leadership to teams of individual contributors. - Proven ability to lead and implement regulatory strategies in alignment with internal standards and technical guidelines.
- Proficient in writing, reviewing, and providing training on regulatory submissions and business correspondence.
- Excellent communication skills with experience presenting to regulatory agencies, management, and teams.
MS Office proficiency and general IT skills.
Why VB Spine?
At VB Spine, we are more than just a medical device company—we are building a legacy of excellence, innovation, and patient-centered care. Join a team where you will have the opportunity to influence growth, strategy, and innovation across the organization while advancing in your career.
Compensation:
Pay for this role is competitive and based on experience, with additional factors like territory requirements, qualifications, and performance taken into account. The typical pay range for this position is $160,000.00 - $175,000.00 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, skillset, 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 for growth within a fast-paced, dynamic company