BIOTRONIK is one of the leading manufacturers of cardio and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

California Research Center Electrophysiology, Inc (CRC EP, Inc.), a Biotronik business unit 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 for treatment of atrial fibrillation. The team is embarking on preparing the technology for regulatory approvals followed by commercial release in respective territories. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

We are seeking a highly experienced Principal Clinical Research Analyst - Class III Medical Devices (EU MDR Clinical Affairs Expert) to provide strategic leadership and technical expertise in clinical evaluation, clinical evidence generation, and regulatory compliance for Class III medical devices. The ideal candidate will possess more than 7 years of experience in clinical affairs, clinical research, and regulatory support within the medical device industry, with extensive expertise in the requirements of the European Union Medical Device Regulation (EU MDR 2017/745). This role will serve as a subject matter expert (SME) for clinical evaluation and evidence strategies, partnering closely with Regulatory Affairs, Quality and Engineering teams to ensure clinical compliance throughout the product lifecycle.

Key Responsibilities

Clinical Evaluation & Regulatory Strategy

• 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.

Clinical Research & Evidence Generation

• 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.

Data Analysis & Scientific Leadership

• 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.

Cross-Functional Collaboration

• 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.

Your Profile

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

Additional Preferred Knowledge, Skills and Abilities

• Experience with cardiovascular, neurovascular, structural heart, electrophysiology or implantable Class III medical devices.
• Experience working directly with European Notified Bodies.
• Knowledge of global clinical regulatory requirements, including FDA clinical evidence expectations and international regulatory frameworks.
• Statistical analysis experience and familiarity with clinical databases and scientific literature platforms.

Competencies

• Expert knowledge of EU MDR clinical affairs requirements.
• Strong scientific writing and technical documentation skills.
• Exceptional analytical and critical-thinking abilities.
• Ability to influence cross-functional teams and senior stakeholders.
• Excellent presentation and communication skills.
• Strategic mindset with strong attention to detail.
• Ability to manage multiple complex projects simultaneously.

Success Measures

Within the first 12 months, the Principal Clinical Research Analyst will:

• Create and maintain multiple CER and PMCF deliverables for Class III devices with successful Notified Body acceptance.
• Establish robust clinical evidence strategies aligned with EU MDR requirements. Create PMS Plans, PSURs.
• Identify and mitigate clinical evidence gaps proactively.
• Serve as the organization's recognized SME for EU MDR clinical evaluation and clinical evidence generation.

Physical and Travel Requirements

The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer for extended periods of time and communicate with co-workers.
• Must be able to work a minimum of 40 hours / week. Minimum to no work-from-home opportunity.
• Must be able to work onsite at our Tustin, CA facility. No relocation support will be provided.
• Must be able to travel internationally and domestically, up to 25% of the time for audits, investigator meetings, and regulatory interactions.

Work Location

This role follows a hybrid schedule and requires working onsite at our Tustin, CA office.

Work Environment

This position is performed primarily in a professional office environment and requires regular use of a computer, standard office equipment, clinical and regulatory databases, and virtual communication tools. Work involves extended periods of sitting, reading, writing, typing, document review, and participation in meetings, with occasional travel to support audits, investigator meetings, regulatory interactions, or other business needs. The employee is expected to maintain confidentiality and comply with applicable company policies, quality system requirements, and regulatory standards. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.

What We Offer

• 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.

BIOTRONIK EP CRC is dedicated to fair and equitable compensation practices. The base salary range for this position is $165,000 - $185,000 per year, based on experience and qualifications. In addition to base salary, BIOTRONIK EP CRC offers a bonus program and comprehensive benefits package, which includes health insurance, retirement plans, paid time off, and other perks. Compensation may vary depending on geographic location, skills, experience, and other factors.

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Tustin, CA | Working hours: Full-time | Type of contract: Unlimited

Apply now under: www.biotronik.com/careers

Job ID: 62423 BIOTRONIK CRC Inc. USA

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Pay: $165,000.00 - $185,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Work Location: Hybrid remote in Tustin, CA 92780