Post Market Surveillance Specialist

Actalent • Minneapolis, MN • 4w ago

Job Title: Post Market Surveillance SpecialistJob Description

As a Post Market Surveillance Specialist, you will play a crucial role in maintaining complete complaint files by updating the product report database with new information and documentation from field personnel and Engineering. You will ensure regulatory and compliance requirements related to the complaint system process are fulfilled. This role involves computer and telephone-based work for extended periods in an office environment and may require coverage on occasional company holidays. You will document product and therapy-related field reports within prescribed timelines, provide necessary documents for investigations, and follow up with reporting as needed. Additionally, you will complete training requirements and competency confirmations in a timely manner and comply with applicable quality system procedures/policies, making suggestions for continuous process improvement.

Responsibilities

Maintain complete complaint files by updating the product report database with new information and documentation.

Communicate effectively with field personnel to ensure efficient and effective handling of complaints.

Ensure fulfillment of regulatory and compliance requirements related to the complaint system process.

Document product and therapy-related field reports within prescribed timelines and provide necessary documents for investigations.

Provide follow-up reporting as needed.

Complete training requirements and competency confirmations as required within the required timeline.

Comply with applicable quality system procedures/policies and suggest continuous process improvements.

Document and evaluate new product reports according to required timelines for escalation, risk, coding, and complaint designation.

Facilitate product return process, disposition products, and ensure documentation of return date and disposition status.

Lead product report and patient follow-up activities and document results.

Lead investigations as assigned and provide returned product kits to field personnel.

Run basic complaint handling reports from the product reporting system.

Compile data for regulatory reports as needed.

Compose written communications to physicians and other end-use customers as directed.

Train various team members on the complaint handling process and system.

Essential Skills

2+ years experience in complaint or regulatory handling.

Understanding of FDA/ISO certified environment.

Knowledge of medical device terminology.

Proficiency in surveillance and documentation review.

Expertise in biotechnology and complaint analysis.

Additional Skills & Qualifications

Ability to document and evaluate new product reports in accordance with required timelines.

Experience in facilitating product return processes and documenting disposition status.

Skill in leading product report and patient follow-up activities.

Competency in compiling data for regulatory reports.

Ability to compose written communications to physicians and end-use customers.

Experience in training team members on complaint handling processes.

Work Environment

This position requires the ability to work second shift hours (1PM - 9PM or Noon - 8PM) within an office environment. The role involves extended periods of computer and telephone-based work. Occasionally, coverage may be required on company holidays.

Pay and Benefits

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

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)

Workplace Type

This is a fully onsite position in Minneapolis,MN.

Application Deadline

This position is anticipated to close on Jun 6, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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