Coloplast · 1 week ago
Post Market Surveillance Specialist
Minneapolis, MN
Full-time
Onsite
New Grad, Entry Level
$71K/yr - $106K/yrColoplast is a leading medical device company that develops and markets products for intimate healthcare needs. The Post Market Surveillance Specialist is responsible for supporting post market surveillance activities, ensuring compliance with regulatory standards and managing customer complaints effectively.
Health CareManufacturingMedical Device
Responsibilities
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
Qualification
Required
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 oriented
Intermediate to advanced level expertise using MS Office applications (Word, Excel, PowerPoint)
Ability to work individually and collaboratively with a team
Ability to multi-task
Preferred
BA/BS in a life sciences field is desired
Degree in a technical or life sciences discipline is desired
Experience in a medical device development or manufacturing environment is desired
Experience with Class II and Class III implantable medical devices is desired
Benefits
Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy.
Access to company sponsored wellness programs and mental health resources.
Paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
A competitive 401(k) plan with company match that vest immediately.
Financial planning services to help you secure your future.
Corporate discount programs for goods and services.
Generous paid time off.
Flexible work hours.
Flexible work arrangement options to help you balance your personal and professional life may be available.
Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
A supportive work environment where everyone feels valued, and has a sense of belonging.
Participate in team-building activities, volunteer opportunities, and company-sponsored events.
Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
Company
Coloplast
Coloplast is a manufacturer of medical devices that offers ostomy, continence, and wound care products.
Founded in 1957
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$1.34B2023-08-29Post Ipo Equity· $1.34B
2000-02-04IPO
Leadership Team
Lars Rasmussen
Chairman of the Board of Directors
Recent News
Essential Business
2025-12-20
2025-12-18
2025-12-05
Company data provided by crunchbase