Senior Staff Clinical Regulatory Scientist

Senior Staff Clinical Regulatory Scientist

Location: 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 surgeons during 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 Senior Staff Clinical Regulatory Scientist, this role is responsible for evaluating and establishing the clinical evidence strategy for new and existing medical devices. It is responsible for the planning, creating, and updating documentation, such as Clinical Evaluation Plans and Reports (CEPs/CERs), Post Market Clinical Follow-up (PMCF) documents, and Summary of Safety and Clinical Performance (SSCPs) documents, to establish and maintain medical devices on global markets. This role is responsible for assessing compliance with internal and external safety and performance requirements for medical devices, by reviewing, analyzing, and concluding on clinical evidence. It leads complex projects, participates in dialog with regulatory agencies, contributes to determining long-term overarching departmental strategies, and provides inputs on regulatory and clinical trends. This role bears the operational and regulatory responsibility of individual deliverables and may defend them in audit situations. Candidates should ideally be located in Leesburg, VA or Allendale, NJ.

What You’ll Do:

Act as a dedicated clinical evaluation project manager, driving the establishment of a coherent clinical evidence strategy throughout the new product development cycle and fostering alignment with adjacent processes as applicable (e.g., marketing strategy and claims, regulatory strategy, clinical research strategy, preclinical testing strategy).
Develop and implement a comprehensive clinical evidence strategy throughout the new product development cycle, considering regulatory requirements, intended use, and risk classification.
Collaborate cross-functionally to provide input to design teams for global regulatory submissions.
Develop global clinical development plans for all key regions, including new and existing markets.
Communicate and negotiate with regulators on clinical evidence requirements to ensure the successful acceptance of regulatory submissions.
Oversee clinical regulatory documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g., CERs, CEPs, PMCF Reports, PMCF Plans, SSCPs).
Design compliant and sustainable literature search strategies and perform systematic reviews to capture and summarize published clinical data.
Analyze current medical and scientific trends in the clinical state of the art on a broad variety of specialized indications and techniques.
Identify, appraise, and analyze relevant clinical, post-market surveillance, marketing, and preclinical testing data to create comprehensive scientific reviews, which may include in-depth quantitative analyses, qualitative analyses, and risk management cross-checks.
Form a conclusion on the overall benefit-risk profile of the subject device in collaboration with a Medical Expert and other stakeholders, based on up-to-date global regulatory requirements.
Identify unanswered questions and residual risks in the clinical evidence and collaborate with Clinical Affairs to design post market clinical follow up activities to address these questions.
Represent expertise during internal and external quality system audits.

What You Bring:

A minimum of a bachelor’s degree (BA or BS) in a technical and/or scientific discipline required.
Master’s or Ph.D. or other higher degree in health-related field (Eng, Sci, RN, BSN, BPharm/MD/MPH) is highly preferred
6+ years of industry experience in clinical, quality, or regulatory affairs (Risk Management, Design quality, Post Market Safety etc.) including 2-4 yrs. experience in clinical evaluation in the medical device industry
4+ years of experience in scientific or medical writing, relevant academic or clinical research experience (PhD, Post-doc, BSN) is preferred.
Expert knowledge and comprehensive understanding of global clinical evaluation regulations is required.
Excellent scientific and medical writing skills are required.
Demonstrated ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
Demonstrated successful track record in managing complex projects.
Demonstrated ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external (Physicians, CROs, Medical Staff, etc.) stakeholders.
Demonstrated ability to lead small teams of individual contributors working on scientific or technical topics.
Documented expertise in one or more disciplines linked to clinical evaluation (e.g. regulatory requirements, data analysis, critical appraisal, etc.)
Ability to write, review, and provide training on detailed technical regulatory submissions, reports, and business correspondence.
Ability to train and mentor junior team members.
Demonstrated ability to drive innovation and set direction within the group in internal procedures and best practices.
Ability to effectively present information to other employees, management, and regulatory agencies.

Solicit input from managers and exercise independent judgment in providing recommendations to the business.

Effectively facilitate discussions with and deliver communications to large groups of people.

The physical and mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee is frequently required to use hands to finger, handle, or feel and talk or hear. The vision requirements include close vision, depth perception, and ability to adjust focus.

Why VB Spine?

We believe in growing talent from within. At VB Spine, join a high-performing team, benefit from peer and executive mentorship, and shape strategy in the dynamic field of medical sales—positioning yourself to influence growth and innovation across the organization.

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 $120,000.00 - $170,000.00 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 to grow within a fast-paced, dynamic company