Coloplast
Post Market Surveillance Specialist
This position is essential to the compliance of Coloplast with FDA and international regulatory authorities. It is responsible for supporting the post‑market surveillance activities for the Interventional Urology (IU) Business Unit.
Major Areas of Accountability
Receives and processes customer complaints in accordance with FDA, ISO 13485 and other regulatory requirements; documents them in the complaint handling database.
Contact hospitals, physicians’ offices or sales representatives to request product returns and additional information for investigating complaints.
Coordinate with outside suppliers (custom‑manufactured (CM) products) to evaluate returned product responses and document findings.
Support senior PMS specialists with complaint investigations, including checking in returned devices.
Write correspondence to physicians’ offices regarding investigation results and conclusions.
Support closure of complaint files and maintain their security.
Work with other Product Evaluation team members to prioritize daily activities.
Take initiative to resolve all product complaints promptly.
Alert the Post Market QA Manager of unusual or high‑risk events requiring review by Legal or Regulatory Affairs.
Maintain the order, cleanliness, equipment calibration, and lab supply inventory.
Maintain complaint records in a secure environment and in accordance with US record‑retention policies.
Create tailored complaint reports for Corporate, Local Management, Regulatory, Research & Development and other departments upon request.
Maintain the Implant Registry database.
Perform additional duties as assigned.
Basic Qualifications
BA/BS in a life sciences field (desired).
Degree in a technical or life sciences discipline (desired).
Experience in a medical device development or manufacturing environment (desired).
Experience with Class II and Class III implantable medical devices (desired).
Knowledge, Skills & Abilities
Excellent verbal and written English communication skills.
Structured and methodical problem‑solving approach.
Knowledge and application of FDA, MDSAP, EU MDR, ISO 13485 and ISO 14971 requirements.
Strong attention to detail and deadline orientation.
Intermediate to advanced proficiency with MS Office (Word, Excel, PowerPoint).
Ability to work individually and collaboratively in a team.
Ability to multi‑task.
Benefits
Health and Wellness: Comprehensive medical, dental, vision insurance, wellness programs, paid leave, and generous parental leave.
Financial Security: Competitive 401(k) plan with immediate match, financial planning services, and corporate discount programs.
Work‑Life Balance: Generous paid time off, flexible work hours, and remote work options.
Professional Development: Continuous learning, mentorship, and tuition reimbursement.
Recognition and Rewards: Peer recognition, bonuses, awards, and special events.
Community and Culture: Supportive environment, team‑building activities, volunteer opportunities, and sustainability strategy.
Competitive Compensation: $70,941–$106,412 base salary with potential bonuses and incentives.
Equal Employment Opportunity Statement Coloplast is committed to a policy of Equal Employment Opportunity (EEO) and employs and promotes individuals based on merit, 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, public assistance status, or any other protected classification.
#J-18808-Ljbffr
Major Areas of Accountability
Receives and processes customer complaints in accordance with FDA, ISO 13485 and other regulatory requirements; documents them in the complaint handling database.
Contact hospitals, physicians’ offices or sales representatives to request product returns and additional information for investigating complaints.
Coordinate with outside suppliers (custom‑manufactured (CM) products) to evaluate returned product responses and document findings.
Support senior PMS specialists with complaint investigations, including checking in returned devices.
Write correspondence to physicians’ offices regarding investigation results and conclusions.
Support closure of complaint files and maintain their security.
Work with other Product Evaluation team members to prioritize daily activities.
Take initiative to resolve all product complaints promptly.
Alert the Post Market QA Manager of unusual or high‑risk events requiring review by Legal or Regulatory Affairs.
Maintain the order, cleanliness, equipment calibration, and lab supply inventory.
Maintain complaint records in a secure environment and in accordance with US record‑retention policies.
Create tailored complaint reports for Corporate, Local Management, Regulatory, Research & Development and other departments upon request.
Maintain the Implant Registry database.
Perform additional duties as assigned.
Basic Qualifications
BA/BS in a life sciences field (desired).
Degree in a technical or life sciences discipline (desired).
Experience in a medical device development or manufacturing environment (desired).
Experience with Class II and Class III implantable medical devices (desired).
Knowledge, Skills & Abilities
Excellent verbal and written English communication skills.
Structured and methodical problem‑solving approach.
Knowledge and application of FDA, MDSAP, EU MDR, ISO 13485 and ISO 14971 requirements.
Strong attention to detail and deadline orientation.
Intermediate to advanced proficiency with MS Office (Word, Excel, PowerPoint).
Ability to work individually and collaboratively in a team.
Ability to multi‑task.
Benefits
Health and Wellness: Comprehensive medical, dental, vision insurance, wellness programs, paid leave, and generous parental leave.
Financial Security: Competitive 401(k) plan with immediate match, financial planning services, and corporate discount programs.
Work‑Life Balance: Generous paid time off, flexible work hours, and remote work options.
Professional Development: Continuous learning, mentorship, and tuition reimbursement.
Recognition and Rewards: Peer recognition, bonuses, awards, and special events.
Community and Culture: Supportive environment, team‑building activities, volunteer opportunities, and sustainability strategy.
Competitive Compensation: $70,941–$106,412 base salary with potential bonuses and incentives.
Equal Employment Opportunity Statement Coloplast is committed to a policy of Equal Employment Opportunity (EEO) and employs and promotes individuals based on merit, 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, public assistance status, or any other protected classification.
#J-18808-Ljbffr