Post Market Surveillance Specialist

Actalent; Minneapolis (MN); Vor Ort; USD 34.000 - 48.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) Retirement Plan

PTO / Vacation or Sick Leave

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Complaint handling

Regulatory handling

FDA/ISO knowledge

Root cause analysis

Documentation review

Cross-functional collaboration

Ausbildung

Bachelor's degree in engineering/quality or related

Jobbeschreibung

Job Title: 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

• 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.

• 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.

Job Type & Location

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

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 Minneapolis, MN.

Application Deadline

This position is anticipated to close on Oct 21, 2026.

Workplace Type

This is a fully onsite position in Minneapolis,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.