Regulatory Post-Market Surveillance Engineer II

Integer Holdings Corporation; Plymouth (MN); On-site; USD 71,000 - 104,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan with company match

Job summary

Integer Holdings Corporation is seeking a Post Market Surveillance Engineer II in Minnesota. The role focuses on executing and supporting complaint handling, regulatory reporting, and post-market surveillance processes in accordance with FDA 21 CFR and other regulatory requirements.

You will document complaints, conduct investigations, and collaborate with cross-functional teams to ensure timely, compliant outcomes.

Qualifications

• Bachelor's degree and at least 1 year of relevant experience in medical device, regulated industry, or similar field.
• Demonstrated ability to perform and document complaint investigations with cross-functional teams.
• Strong written and verbal communication skills with attention to detail.

Responsibilities

• Execute and support Complaint Handling, Regulatory Reporting, and Post Market Surveillance per FDA and other regulatory bodies.
• Capture and document complaints in the database per internal policies.
• Perform complaint investigations and communicate findings to customers and stakeholders.

Skills

Technical aptitude

Written communications

Oral communications

Microsoft Office

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Integer Holdings Corporation is seeking a Post Market Surveillance Engineer II in Minnesota. The role focuses on executing and supporting complaint handling, regulatory reporting, and post-market surveillance processes in accordance with FDA 21 CFR and other regulatory requirements.

You will document complaints, conduct investigations, and collaborate with cross-functional teams to ensure timely, compliant outcomes.