Post Market Surveillance Specialist

Job Title:

Post Market Surveillance Specialist

The Post Market Surveillance Specialist reviews and investigates medical device complaints, evaluates device performance against specifications, and determines regulatory reportability to global agencies. This role focuses on thorough complaint analysis, documentation review, and quality assurance within a regulated FDA/ISO medical device environment, ensuring that post-market data is accurately assessed and handled in compliance with internal procedures and regulatory requirements.

• Review complaint narratives and all available supporting information to clearly understand the reported event and device allegation.

• Determine what additional information is necessary to adequately investigate each complaint and request this information as needed.

• Review follow-up information obtained from patients, healthcare professionals, distributors, field personnel, or other relevant sources.

• Evaluate reported device behavior against intended device performance, design specifications, and applicable requirements.

• Assess whether the available evidence supports or contradicts the reported complaint condition and document conclusions clearly.

• Collaborate with root cause and laboratory analysis teams to interpret findings related to device performance and failure modes.

• After completion of root cause and lab analysis, determine whether the complaint is reportable to the FDA or other global regulatory agencies.

• Apply a strong understanding of regulatory regulations and internal procedures to make sound regulatory decisions with minimal oversight.

• Handle complaint documentation in a controlled manner, ensuring accurate, complete, and timely records in accordance with document control requirements.

• Support post-market quality and surveillance activities by identifying trends, potential risks, and opportunities for product or process improvement.

• Ensure that all complaint handling activities align with FDA, ISO, and internal quality system requirements.

• Communicate findings and decisions clearly to quality, regulatory, and other cross-functional stakeholders as needed.

• 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.

• Knowledge of root cause failure analysis principles and the ability to work with technical teams to interpret investigation results.

• Strong quality assurance mindset with meticulous attention to detail and adherence to procedures.

• Ability to follow internal documentation and regulatory regulations very strictly with little oversight.

• Proficiency in working within a surveillance and post-market monitoring framework for medical devices.

• Bachelor's degree in engineering, quality, or a related discipline preferred, or an equivalent combination of education and relevant medical device experience.

• Education or experience suited to performing technical analysis for complaint investigation in a medical device setting.

• Experience working with medical devices used in obstructive sleep apnea therapy or similar clinical applications is beneficial.

• Familiarity with quality systems in biotechnology or medical device organizations.

• Strong analytical and critical thinking skills to evaluate complex complaint data and technical information.

• Effective written communication skills for clear documentation of complaint investigations and regulatory decisions.

• Ability to collaborate with cross-functional teams, including quality, regulatory, manufacturing, and field personnel.

This is a Contract position based out of Minneapolis, MN.

The pay range for this position is $25.00 - $35.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements…