Post-Market QA & Regulatory Investigator

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

Job summary

Actalent in Plymouth, MN is seeking a Post Market Surveillance Specialist to review medical device complaints, evaluate performance against specifications, and determine regulatory reportability to FDA and other global agencies. You will conduct thorough complaint analyses, coordinate with root cause and laboratory teams, and ensure compliant documentation in alignment with FDA/ISO requirements.

This is a contract onsite role focused on post‑market quality surveillance, trend identification, and

Qualifications

• At least 1 year of experience in complaint handling or regulatory handling within a medical device or similarly regulated environment.
• Hands‑on experience in medical device complaint investigation, technical product support, post‑market quality, manufacturing quality, or failure investigation.
• Understanding of FDA and ISO‑certified environments, including applicable regulations and quality system requirements.
• Experience with complaint analysis and documentation review in a biotechnology or medical device context.
• Ability to interpret and apply regulatory agency requirements when assessing complaint reportability.

Responsibilities

• Review complaint narratives and supporting information to understand the event and device allegation.
• Determine what additional information is necessary and request it as needed.
• Review follow-up information from patients, clinicians, distributors, field personnel, or other sources.
• Evaluate device behavior against specifications and requirements.
• Assess whether evidence supports or contradicts the reported complaint and document conclusions.
• Collaborate with root cause and laboratory teams to interpret findings.
• After analysis, determine whether the complaint is reportable to the FDA or other global agencies.
• Apply regulatory knowledge to make sound decisions with minimal oversight.
• Handle complaint documentation ensuring accuracy, completeness, and timeliness.
• Identify trends and opportunities for product or process improvement.
• Ensure all activities align with FDA, ISO, and internal quality system requirements.
• Communicate findings to quality, regulatory, and cross‑functional stakeholders.

Skills

Complaint handling

Regulatory handling

FDA/ISO knowledge

Complaint investigation

Documentation review

Root cause analysis

Cross-functional collaboration

Attention to detail

Surveillance experience

Education

Bachelor's degree in engineering/quality

Job description

Actalent in Plymouth, MN is seeking a Post Market Surveillance Specialist to review medical device complaints, evaluate performance against specifications, and determine regulatory reportability to FDA and other global agencies. You will conduct thorough complaint analyses, coordinate with root cause and laboratory teams, and ensure compliant documentation in alignment with FDA/ISO requirements.

This is a contract onsite role focused on post‑market quality surveillance, trend identification, and