Post Market Surveillance Specialist

Seeking a 2nd Shift Post Market Surveillance Specialist!

Job Description

As a Post Market Surveillance Specialist, you will maintain complete complaint files by updating the product report database with new information and documentation from both field personnel and Engineering. You will communicate effectively with field personnel to ensure complaints are handled efficiently and effectively, and ensure regulatory and compliance requirements related to the complaint system process are fulfilled. This role requires computer and telephone-based work for extended periods of time in an office environment and may require coverage on occasional company holidays. You will document product and therapy-related field reports within the prescribed timelines, complete training requirements and competency confirmations, and comply with applicable quality system procedures/policies while 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 complaints are handled efficiently and effectively.

• Ensure regulatory and compliance requirements related to the complaint system process are fulfilled.

• Document product and therapy-related field reports within the prescribed timelines.

• Provide follow-up reporting as needed.

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

• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.

• Document and evaluate new product reports in accordance with required timelines for escalation, risk, coding, and complaint designation.

• Facilitate the product return process, disposition products, and ensure return date and disposition status are documented.

• Lead product report and patient follow-up activities and document the 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 regarding return receipt and other end-use customers as directed.

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

Essential Skills

• 2+ years of experience in complaint or regulatory handling.

• Understanding of FDA/ISO certified environment.

• Knowledge of medical device terminology.

• Proficiency in complaint handling, document control, and record keeping.

• Experience in surveillance and documentation review.

• Ability to conduct complaint analysis.

Additional Skills & Qualifications

• Ability to document and evaluate new product reports within required timelines.

• Experience in facilitating the product return process and ensuring proper documentation of return date and disposition status.

• Capability to lead product report and patient follow-up activities and document results.

• Experience in leading investigations and providing returned product kits to field personnel.

• Proficiency in running basic complaint handling reports and compiling data for regulatory reports.

• Excellent written communication skills for composing communications to physicians and end-use customers.

Work Environment

This role requires working second shift hours (1 PM - 9 PM or Noon - 8 PM). The position involves computer and telephone-based work for extended periods in an office environment.

Pay and Benefits

The pay range for this position is $30.00 - $35.00

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 hybrid position in Minneapolis,MN.

Application Deadline

This position will be accepting applications until Jan 1, 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 ~~~ (~~~) for other accommodation options.