Senior Clinical Research Lead — EU MDR & Class III Devices

BIOTRONIK; Tustin (CA); Hybrid; USD 165,000 - 185,000; Full time

Benefits offered by this job

Negotiable bonus potential

Hybrid schedule

Onsite in Tustin

Comprehensive benefits

Job summary

BIOTRONIK seeks a Principal Clinical Research Analyst in Tustin, CA to lead clinical evaluation and regulatory strategies for Class III devices. You will drive CER/PMCF programs, perform evidence analyses, and collaborate with Regulatory, Quality, and Engineering teams to ensure lifecycle regulatory compliance.

The role requires extensive EU MDR experience, strong scientific writing, and cross-functional leadership. Hybrid onsite work at the Tustin facility is offered.

Qualifications

• Minimum 7+ years of progressive experience in Clinical Affairs, Clinical Research, Medical Writing, or Regulatory Affairs within medical devices.
• Experience supporting Class III devices throughout the product lifecycle and CERs under EU MDR.
• Strong writing, analytical, and regulatory submission skills.

Responsibilities

• Lead CERs and PMCF deliverables for Class III devices and Notified Body interactions.
• Develop clinical evidence strategies aligned with EU MDR requirements.
• Collaborate with Regulatory, Quality, and Engineering teams to ensure regulatory compliance.

Skills

Clinical affairs

Clinical research

Regulatory affairs

Regulatory strategy

Statistical analysis

Education

Bachelor's degree

Advanced degree preferred

Job description

BIOTRONIK seeks a Principal Clinical Research Analyst in Tustin, CA to lead clinical evaluation and regulatory strategies for Class III devices. You will drive CER/PMCF programs, perform evidence analyses, and collaborate with Regulatory, Quality, and Engineering teams to ensure lifecycle regulatory compliance.

The role requires extensive EU MDR experience, strong scientific writing, and cross-functional leadership. Hybrid onsite work at the Tustin facility is offered.