Post Market Surveillance Specialist

Actalent; Golden Valley (MN); On-site; USD 34,000 - 48,000; Part time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Paid time off

Job summary

Actalent is seeking a Post Market Surveillance Specialist in Golden Valley, MN for a contract onsite role. You will review medical device complaints, assess device performance, and determine regulatory reportability to global agencies in a regulated FDA/ISO environment.

Responsibilities include examining complaint narratives, obtaining necessary information, collaborating with root cause and lab teams, and documenting conclusions clearly to support post-market quality and surveillance

Qualifications

• Review complaint narratives and supporting information to understand the event.
• Determine additional information needed for investigation.
• Review follow-up information from patients, healthcare professionals, distributors, or field personnel.
• Evaluate device behavior against specifications and requirements.
• Assess evidence to support or contradict the reported condition and document conclusions.
• Collaborate with root cause and lab teams to interpret findings.
• Determine FDA or global regulatory reportability after analysis.
• Ensure complaint handling complies with FDA, ISO, and internal procedures.
• Document records accurately and timely per document control.
• Identify trends and potential risks to support product or process improvements.
• Communicate findings to quality, regulatory, and cross-functional stakeholders.

Responsibilities

• Review complaint narratives and supporting information to understand the event.
• Determine additional information needed for investigation.
• Review follow-up information from patients, healthcare professionals, distributors, or field personnel.
• Evaluate device behavior against specifications and requirements.
• Assess evidence to support or contradict the reported condition and document conclusions.
• Collaborate with root cause and lab teams to interpret findings.
• Determine FDA or global regulatory reportability after analysis.
• Ensure complaint handling complies with FDA, ISO, and internal procedures.
• Document records accurately and timely per document control.
• Identify trends and potential risks to support product or process improvements.
• Communicate findings to quality, regulatory, and cross-functional stakeholders.

Skills

Complaint handling

Regulatory knowledge

Root cause analysis

Documentation review

Communication skills

Attention to detail

Collaboration

Medical device experience

FDA/ISO familiarity

Education

Bachelor's degree in engineering, quality, or related discipline

Job description

Post Market Surveillance Specialist Job Description 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. Responsibilities

Responsibilities

• - 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.

Essential Skills

• - 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.

Additional Skills & Qualifications

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

Pay and Benefits

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 apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of Golden Valley, MN.

Application Deadline

This position is anticipated to close on Nov 5, 2026.

Workplace Type

This is a fully onsite position in Golden Valley,MN.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.