EU MDR Clinical Lead for Class III Cardiac Devices

BIOTRONIK; Minneapolis (MN); On-site; USD 165,000 - 185,000; Full time

Benefits offered by this job

Competitive salary

Bonus program

Comprehensive benefits

Health insurance

Retirement plans

Paid time off

Job summary

BIOTRONIK EP CRC is seeking a Principal Clinical Research Analyst to lead clinical evaluation, regulatory strategy, and evidence generation for Class III devices. You will partner with Regulatory, Quality and Engineering to ensure EU MDR compliance across the lifecycle.

The role requires 7+ years in clinical affairs or regulatory roles, CER authoring experience, and strong leadership in PMCF/PSUR programs. Onsite in Tustin, CA with hybrid work options and a competitive package.

Qualifications

• Minimum 7+ years of 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.
• 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.

Responsibilities

• Lead CER development and maintenance per EU MDR Annex XIV.
• Develop comprehensive clinical evidence strategies for Class III devices.
• Interpret EU MDR requirements to support regulatory submissions and lifecycle management.
• Support PMS, PMCF, and PSUR activities and benefit-risk determinations.
• Collaborate with Regulatory, Quality, and Engineering for clinical evidence alignment.
• Present clinical findings to executives and cross-functional teams.

Skills

EU MDR

CERs authoring

PMCF planning

Notified Bodies collaboration

clinical data analysis

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Tools

ISO 14155

ISO 14971

MDCG guidance documents

Job description

BIOTRONIK EP CRC is seeking a Principal Clinical Research Analyst to lead clinical evaluation, regulatory strategy, and evidence generation for Class III devices. You will partner with Regulatory, Quality and Engineering to ensure EU MDR compliance across the lifecycle.

The role requires 7+ years in clinical affairs or regulatory roles, CER authoring experience, and strong leadership in PMCF/PSUR programs. Onsite in Tustin, CA with hybrid work options and a competitive package.