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Post Market Surveillance Specialist

Location : Minneapolis, MN, US

Job Family : Quality Assurance

Country / Region : United States

This position is essential to the compliance of the company with FDA and international regulatory authorities. This position is responsible for supporting the post market surveillance activities for Interventional Urology (IU) Business Unit.

Major Areas of Accountability

• Receives and processes customer complaints in accordance with FDA, ISO 13485 and other regulatory from written, electronic, and oral communications are entered the complaint handling database in accordance with procedure.
• Contacts hospital, physician's office or sales representative to request product returns and additional information to adequately investigate a customer complaint.
• Coordinates with outside suppliers (CM products) the evaluation response for returned product and documents these findings in the complaint handling database
• Supports Sr. PMS specialists for complaint investigations such as checking-in returned devices
• Writes correspondence to the physician's office regarding results and conclusions of the complaint investigation
• Supports closure of complaint files
• Work with other Product Evaluation team members to determine prioritization of daily activities.
• Takes initiative and action to respond, resolve, and follow up on all product complaints in a timely manner.
• Alerts the Post Market QA Manager of unusual or high-risk events requiring review by Legal or Regulatory Affairs
• Maintains order, cleanliness, equipment calibration and PE lab supply inventory.
• Responsible for maintaining complaint files within a secured environment.
• Creates tailored complaint reports for Corporate, Local Management, Regulatory, Research & Development, and other departments upon request
• Maintains and retains complaint records in accordance with the US record retention policy
• Maintains the Implant Registry database
• Additional duties as assigned

Basic Qualifications

Knowledge, Skills & Abilities

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect :

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.

Visit us on Coloplast.com .

Watch the film. Follow us on LinkedIn . Like us on Facebook .

Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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Nearest Major Market : Minneapolis

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