Post Market Surveillance Specialist

Job Title: Post Market Surveillance Specialist

Job Description

This position is essential to ensuring compliance with FDA and international regulatory authorities. The specialist will be responsible for receiving, evaluating, and processing customer and product complaints, focusing on Coloplast products. This role is customer-focused and involves daily interactions with internal and external customers.

Responsibilities

• Receive and process customer complaints in accordance with FDA, ISO, and other regulatory standards, entering information into the complaint handling database.
• Contact hospitals, physician's offices, or sales representatives to request product returns and additional information for thorough investigation of complaints.
• Coordinate with outside suppliers on evaluation responses for returned products and document findings in the complaint handling database.
• Support Senior Post Market Surveillance Specialists in complaint investigations, including checking in returned devices.
• Write correspondence to physician's offices regarding results and conclusions of complaint investigations.
• Support the closure of complaint files and work with the Product Evaluation team to prioritize daily activities.
• Take initiative to respond, resolve, and follow up on all product complaints in a timely manner.
• Alert the Post Market QA Manager of unusual or high-risk events requiring review by Legal or Regulatory Affairs.
• Maintain order, cleanliness, equipment calibration, and PE lab supply inventory.
• Ensure complaint files are maintained within a secured environment.
• Create tailored complaint reports for various departments such as Corporate, Local Management, Regulatory, and Research & Development upon request.
• Maintain and retain complaint records in line with the US record retention policy.
• Maintain the Implant Registry database.

Essential Skills

• Experience in complaint analysis and handling within a medical device context.
• Bachelor's Degree in STEM, with a preference for Biomedical Engineering.
• Strong communication skills, both verbal and written, in English.
• Knowledge of ISO standards.
• Intermediate expertise in MS Office applications including Word, Excel, and PowerPoint.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $35.00 - $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 Nov 20, 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 for other accommodation options.

Salary : $35