Post Market Surveillance Specialist
Actalent
Job Title: Post Market Surveillance Specialist
Job Description
We are seeking a dedicated Post Market Surveillance Specialist to join our team. In this role, you will be responsible for maintaining complete complaint files, communicating effectively with field personnel, and ensuring all regulatory and compliance requirements related to the complaint system process are met. This position involves computer and telephone-based work for extended periods in an office environment and may require occasional coverage on company holidays.
Responsibilities
+ Maintain complete complaint files by updating the product report database with new information and documentation from both field personnel and Engineering.
+ 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 prescribed timelines and provide necessary documents required to complete investigations. Provide follow-up reporting as needed.
+ Complete training requirements and competency confirmations within the required timeline.
+ Comply with applicable quality system procedures/policies and suggest continuous process improvements.
+ Document and evaluate new product reports in accordance with required timelines for escalation, risk, coding, and complaint designation.
+ Facilitate 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 processes and systems.
Essential Skills
+ 1+ years of experience in complaint or regulatory handling.
+ Understanding of FDA/ISO certified environment.
+ Knowledge of medical device terminology.
+ Experience in surveillance, documentation review, complaint analysis, and biotechnology.
+ Proficient in using computer systems for documentation and communication.
Additional Skills & Qualifications
+ Ability to document and evaluate new product reports in accordance with required timelines.
+ Facilitate product return processes and ensure proper documentation.
+ Lead and document product report and patient follow-up activities.
+ Compile and analyze data for regulatory reports.
+ Strong written communication skills for interacting with physicians and end-use customers.
+ Ability to train team members on complaint handling processes.
Work Environment
The work environment for this role is office-based with extended periods of computer and telephone use. The position requires availability for second shift hours (1 PM - 9 PM / Noon - 8 PM) and occasional holiday coverage.
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 hybrid position in Minneapolis,MN.
Application Deadline
This position is anticipated to close on Mar 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.
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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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