ABOUT WARWICK CONSULTING
Warwick Consulting is a comprehensive medical device and life sciences consulting firm that simplifies complexity across the full product lifecycle, from concept and design through regulatory approval, commercialization, and post-market support. We partner with organizations ranging from early-stage innovators to global industry leaders, delivering tailored, results-driven solutions across engineering, quality systems, regulatory affairs, cybersecurity, risk management, human factors engineering, product quality, and FDA remediation. By integrating deep industry expertise with innovative, AI-enabled solutions, including our VERA QMS Assurance platform, we help clients address complex challenges, strengthen compliance, improve operational efficiency, and accelerate innovation. Our experienced consultants provide flexible on-site, hybrid, and remote support, delivering the right expertise when and where it is needed most.
Position Overview
Warwick Consulting is seeking an experienced physician to serve as a Fractional Medical Director, providing flexible, as-needed clinical expertise and medical oversight to support client engagements across the medical device and life sciences industries. This role is well suited to a physician with a strong clinical background, an understanding of medical device development and regulatory requirements, and the ability to translate clinical evidence and medical judgment into practical, risk-based recommendations.
The Medical Director will provide both planned and ad hoc support in response to client needs, which may vary throughout the year.Working directly with the client on an as-needed basis, the Fractional Medical Director will provide clinical insights, evaluate safety and performance concerns, and support evidence-based decision-making throughout the product lifecycle. The role may include review of clinical and post-market evidence, benefit-risk assessments, product and design changes, and regulatory submissions and responses.The engagement will be structured on a fractional, flexible basis, with hours and deliverables aligned to client needs and agreed upon in advance where practical.
Key Responsibilities:·
- Clinical and Medical Oversight: Provide clinical expertise and medical judgment to support client projects, product development, and lifecycle decisions.·
- Product and Design Changes: Review proposed product, design, material, and manufacturing changes for potential clinical implications, including impacts on safety, performance, and intended use.·
- Indications and Claims: Evaluate new or revised indications for use, intended purposes, clinical claims, and supporting evidence.·
- Clinical Evidence: Review new and existing clinical investigation data, post-market surveillance (PMS) data, scientific literature, and other relevant evidence.·
- Safety and Performance Assessments: Evaluate product complaints, adverse events, safety signals, and performance concerns; contribute to investigations, root-cause assessments, and benefit-risk determinations.·
- Regulatory and Notified Body Support: Provide clinical input into responses to regulatory authorities and Notified Bodies, including questions related to clinical evidence, safety, performance, and benefit-risk.·
- Clinical Documentation: Review and provide input or approval, as appropriate to the engagement, for Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) plans and reports, Periodic Safety Update Reports (PSURs), and Summaries of Safety and Clinical Performance (SSCPs).·
- Labeling and Technical Documentation: Review labeling, instructions for use, technical documentation, and proposed changes for clinical appropriateness and consistency with the available evidence.·
- Reportability Assessments: Provide medical input into the assessment of adverse events, vigilance reporting, and regulatory reportability.·
- Client Collaboration: Work directly with client stakeholders to understand clinical and product-related challenges and develop clear, actionable recommendations that support patient safety, regulatory compliance, and product performance.·
- Expert Consultation: Provide targeted clinical consultation, written assessments, and participation in client meetings, technical reviews, and regulatory discussions as needed.
Qualifications and Experience:·
- Medical degree (MD or equivalent).·
- At least 10 years of relevant clinical experience, particularly in the clinical application, evaluation, or use of performance fibers and sutures.·
- Active medical license in the country of residence, where applicable to the scope of the engagement.·
- Demonstrated ability to evaluate clinical evidence, medical device safety and performance, and patient benefit-risk.·
- Proven experience communicating clinical assessments and practical recommendations related to safety and performance issues.·
- Strong written and verbal communication skills, including the ability to translate complex clinical and technical issues into clear recommendations.·
- Experience working with multidisciplinary teams across clinical, quality, regulatory, research, or product development functions.·
- Ability to work independently, manage competing priorities, and provide timely guidance in a flexible consulting environment.Preferred·
- Postdoctoral research experience or an advanced research degree.·
- Experience supporting medical device clinical development, clinical investigations, and post-market activities.·
- Experience with medical device regulatory submissions, clinical evaluations, Notified Body interactions, or EU Medical Device Regulation (MDR) requirements.·
- Experience with active implantable medical devices, neuromodulation, surgical devices, or other clinically complex technologies.·
- Clinical experience with performance fibers and sutures, including their clinical application, material or design considerations, safety and performance, or associated clinical evidence.·
- Experience reviewing or contributing to CERs, CEPs, PMCF plans and reports, SSCPs, PMS documentation, or vigilance assessments.·
- Experience supporting product design changes, clinical claims, labeling reviews, and benefit-risk assessments.·
- Experience working with medical device manufacturers, research organizations, or consulting firms.
Engagement Model
This is a fractional consulting opportunity rather than a traditional full-time position. The Medical Director will provide clinical expertise and medical oversight on an as-needed basis, supporting planned deliverables and emerging client needs throughout the year.The workload may vary based on client requirements, with assignments scoped according to project needs, expected availability, and the nature of the clinical support required. Work may be conducted remotely, with occasional participation in client meetings or other activities as appropriate.
Equal Opportunity Employer
We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.
