Medical Device Compliance Engineer — Audits & Regulations

DBA-Verwaltungs-Gmbh; San Diego (CA); On-site; USD 91,000 - 113,000; Full time

Benefits offered by this job

Comprehensive medical benefits

401(k) plan

Tuition assistance

Paid Time Off

Job summary

DBA-Verwaltungs-Gmbh is seeking a Compliance Engineer to enhance compliance for digital health products. You will oversee audits, ensuring adherence to international regulatory standards like MDSAP and ISO13485. You'll collaborate with engineering teams to deliver compliant solutions, conduct safety risk analyses, and drive continuous improvement processes.

This role provides a unique opportunity to make an impact in healthcare technology with a supportive environment that emphasizes professional development. The company offers a comprehensive benefits package including medical, education assistance, and paid time off.

Qualifications

• 3 years of experience with medical product compliance and audits.
• Proficiency in report writing and compliance procedures.
• Thorough understanding of regulatory frameworks.

Responsibilities

• Act as SME for audits of digital products.
• Identify and evaluate design alternatives for compliance.
• Drive bug-triage process affecting patient safety.

Skills

Regulatory knowledge

Communication skills

Risk analysis

Technical design evaluation

Education

BS/MS in engineering or computer science

Job description

DBA-Verwaltungs-Gmbh is seeking a Compliance Engineer to enhance compliance for digital health products. You will oversee audits, ensuring adherence to international regulatory standards like MDSAP and ISO13485. You'll collaborate with engineering teams to deliver compliant solutions, conduct safety risk analyses, and drive continuous improvement processes.

This role provides a unique opportunity to make an impact in healthcare technology with a supportive environment that emphasizes professional development. The company offers a comprehensive benefits package including medical, education assistance, and paid time off.