Medical Device Post-Market Surveillance Analyst

Actalent; Minneapolis (MN); On-site; USD 34,000 - 48,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

PTO / Vacation or Sick Leave

Job summary

Actalent is seeking a Post Market Surveillance Specialist in Minneapolis, MN to review medical device complaints and determine regulatory reportability. You will analyze narratives, collect missing information, and collaborate with cross-functional teams to interpret device performance against specifications.

The role emphasizes meticulous documentation, compliance with FDA/ISO requirements, and identifying trends for product and process improvements in a regulated environment.

Qualifications

• Experience with complaint investigations in a medical device setting.
• Knowledge of regulatory requirements and QA systems.
• Ability to interpret FDA/ISO requirements for reportability.
• Experience with evidence review and technical documentation.
• Proven collaboration with cross-functional teams.

Responsibilities

• Review complaint narratives and supporting information to understand events.
• Determine information needed to investigate each complaint.
• Review follow-up information from patients, professionals, or distributors.
• Evaluate device behavior against specs and requirements.
• Assess evidence to support or refute the complaint condition.
• Collaborate with root cause and lab teams to interpret findings.
• Determine FDA or other regulatory reportability after analysis.
• Apply regulatory knowledge to make decisions with minimal oversight.
• Handle complaint documents with accuracy and control.
• Identify trends and opportunities for improvement in surveillance.
• Ensure alignment with FDA, ISO, and internal quality systems.

Skills

Complaint handling

Regulatory handling

FDA/ISO knowledge

Root cause analysis

Documentation review

Cross-functional collaboration

Education

Bachelor's degree in engineering/quality or related

Job description

Actalent is seeking a Post Market Surveillance Specialist in Minneapolis, MN to review medical device complaints and determine regulatory reportability. You will analyze narratives, collect missing information, and collaborate with cross-functional teams to interpret device performance against specifications.

The role emphasizes meticulous documentation, compliance with FDA/ISO requirements, and identifying trends for product and process improvements in a regulated environment.