Medical Device MDR & Adverse Event Specialist

Terumo Cardiovascular Group; Elkton (MD); On-site; USD 67,000 - 92,000; Full time

Benefits offered by this job

Annual bonus

Paid vacation

Health, dental and vision benefits

401(k) with matching

Job summary

Terumo Medical Corporation in Elkton, MD seeks a QA professional to support Post Market Surveillance and Vigilance through Medical Device Reporting (MDR) for US and global health authorities. You will work with Complaints, Engineering, and Quality to ensure accurate, timely submissions and maintain regulatory documentation.

Responsibilities include audits, process improvements, and cross-training with the team to sustain compliance across Terumo facilities.

Qualifications

• Bachelor's Degree in health or regulatory field; minimum 3 years QA in regulated industry preferred.
• Associated Degree with five years QA in regulated industry acceptable; relevant experience emphasized.

Responsibilities

• Review MDR complaints to confirm reportability and ensure timely submissions.
• Coordinate information requests with global health authorities and internal teams.
• Maintain MDR logs and adverse event files for regulatory compliance and audits.
• Assist with FDA/Notified Body audits and regulatory inquiries; ensure timely reporting.

Skills

Regulatory knowledge

MS Office

Quality Assurance

Education

Bachelor's Degree in health/regulatory field

Associated Degree + 5 years QA experience

Job description

Terumo Medical Corporation in Elkton, MD seeks a QA professional to support Post Market Surveillance and Vigilance through Medical Device Reporting (MDR) for US and global health authorities. You will work with Complaints, Engineering, and Quality to ensure accurate, timely submissions and maintain regulatory documentation.

Responsibilities include audits, process improvements, and cross-training with the team to sustain compliance across Terumo facilities.