Principal Clinical Research Analyst - Class III Medical Devices
About the role
CRC EP, Inc., located in Tustin, CA, develops pulsed-field cardiac ablation (PFA) technologies. The team has recently completed the first-in-human clinical trial which validated the company’s PFA technology. The team is embarking on preparing the technology for regulatory approvals followed by commercial release in respective territories.
Responsibilities
Lead the development and maintenance of Clinical Evaluation Reports (CERs) in accordance with EU MDR Annex XIV and applicable MEDDEV guidance.
Develop comprehensive clinical evidence strategies for Class III cardiac ablation catheters and generators.
Interpret and apply EU MDR clinical requirements to support product development, regulatory submissions, and lifecycle management activities.
Provide strategic guidance regarding clinical data requirements, PMS, PMCF and PSUR activities, and benefit-risk determinations.
Support interactions with Notified Bodies and Competent Authorities regarding clinical evidence and clinical evaluation requirements.
Monitor evolving European regulatory expectations, MDCG guidance documents, harmonized standards, and industry best practices.
Design and oversee clinical investigations, registries, observational studies, and post-market clinical follow-up (PMCF) programs.
Conduct systematic literature reviews and clinical data analyses to support regulatory submissions and clinical evaluations.
Evaluate scientific literature, adverse event data, complaint trends, and post-market surveillance information to establish device safety and performance.
Lead clinical evidence gap assessments and recommend appropriate mitigation strategies.
Develop Clinical Evaluation Plans (CEPs), PMS, PMCF Plans, PMCF Evaluation Reports, PSURs and Summary of Safety and Clinical Performance (SSCP) documentation.
Perform advanced analyses of clinical and post-market data to support safety, efficacy, and performance claims.
Provide statistical interpretation and scientific rationale for clinical conclusions and regulatory positions.
Critically evaluate competitor and predicate device clinical evidence to support strategic regulatory initiatives.
Present clinical findings and recommendations to executive leadership, regulatory bodies, and cross-functional teams.
Partner with Regulatory Affairs to support CE Mark submissions, significant change assessments, and product renewals.
Collaborate with Quality teams to ensure alignment between clinical evidence and risk management documentation.
Support Engineering teams by providing clinical input during product development and design validation activities.
Qualifications
Education Requirements: Bachelor's degree in Life Sciences, Biomedical Engineering, Nursing, Public Health, Clinical Research, or related field. Advanced degree (MS, MPH, PharmD, PhD, MD, or equivalent) strongly preferred.
Experience Requirements: Minimum 7+ years of progressive experience in Clinical Affairs, Clinical Research, Medical Writing, or Regulatory Affairs within the medical device industry. Significant experience supporting Class III medical devices throughout the product lifecycle. Demonstrated experience authoring and maintaining Clinical Evaluation Reports (CERs) under EU MDR. Proven experience supporting Notified Body submissions and clinical evidence reviews. Experience developing PMS, PMCF Plans and creating PSURs. Experience designing or supporting clinical investigations and PMCF studies.
Technical Expertise: Deep working knowledge of: EU MDR 2017/745 MDR Annex XIV (Clinical Evaluation and PMCF) MDR Annex II and Annex III documentation requirements MDCG clinical guidance documents ISO 14155 (Clinical Investigation of Medical Devices) ISO 14971 (Risk Management) Clinical Evaluation Reports (CERs) Clinical Evaluation Plans (CEPs) PMCF Plans and PMCF Evaluation Reports PMS Plans and PSURs Summary of Safety and Clinical Performance (SSCP) Literature review methodologies and evidence appraisal Benefit-risk assessments Post-market surveillance and vigilance requirements
Benefits
Competitive base salary, with a negotiable performance bonus.
Comprehensive benefits package.
Opportunity to shape regulatory strategy for breakthrough cardiac technologies.
A collaborative, mission-driven environment where your expertise has immediate impact.