Job Title: Post Market Surveillance Specialist

Job Description

This position is essential to the compliance of the company with FDA and international regulatory authorities. The Post Market Surveillance Specialist will be responsible for receiving, evaluating, and processing customer/product complaints. This role is very customer-focused and will have daily interactions with internal and external customers.

Responsibilities

• Receive and process customer complaints in accordance with FDA, ISO, and other regulatory standards from written, electronic, and oral communications.
• Enter complaints into the complaint handling database in accordance with procedures.
• Contact hospitals, physician’s offices, or sales representatives to request product returns and additional information to investigate customer complaints adequately.
• Coordinate with outside suppliers for the evaluation response of returned products and document findings in the complaint handling database.
• Support Senior PMS specialists in complaint investigations, such as checking in returned devices.
• Write correspondence to physician’s offices regarding results and conclusions of complaint investigations.
• Support the closure of complaint files.
• Work with other Product Evaluation team members to prioritize daily activities.
• Take initiative and action to respond, resolve, and follow up on all product complaints promptly.
• 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.
• Maintain complaint files within a secured environment.
• Create tailored complaint reports for Corporate, Local Management, Regulatory, Research & Development, and other departments upon request.
• Maintain and retain complaint records in accordance with the US record retention policy.
• Maintain the Implant Registry database.

Essential Skills

• Complaint analysis
• Biomedical engineering
• Complaint handling
• Medical device experience
• Bachelor's Degree in STEM (Biomedical Engineering preferred)
• Strong communication skills
• Quality management

Additional Skills & Qualifications

• Experience in a medical device manufacturing or quality role is desired.
• Excellent verbal and written English communication skills.
• Knowledge of ISO standards.
• Intermediate level expertise using MS Office applications (Word, Excel, PowerPoint).

Work Environment

This role is based in an office setting and is fully on-site. The core hours are from 8 AM to 5 PM, with some flexibility if needed. The team consists of three people: two specialists who deal with complaints daily and one Post Market Analyst who handles post-market plans and trending. There is flexibility to work remotely one day a week every other week. The position offers a specific career path from senior to principal roles, with potential to lead project-based changes in databases, supporting the quality organization.

Pay and Benefits

The pay range for this position is $30.00 - $34.00/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 Apr 11, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $30 - $34