Coloplast is hiring a Post Market Surveillance Specialist to play an essential role in ensuring company compliance with FDA and international regulatory authorities. This position supports all post market surveillance activities for the Interventional Urology (IU) Business Unit.
What You'll Do
- Receive and process customer complaints in accordance with FDA, ISO 13485, and other regulatory requirements, entering them into the complaint handling database.
- Contact hospitals, physician’s offices, or sales representatives to request product returns and additional information for complaint investigations.
- Coordinate with outside suppliers for the evaluation response for returned products and document findings in the complaint handling database.
- Support senior PMS specialists with complaint investigations, including checking-in returned devices.
- Write correspondence to physician’s offices regarding the results and conclusions of complaint investigations.
- Support the closure of complaint files.
- Work with other Product Evaluation team members to determine the prioritization of daily activities.
- Take initiative to respond, resolve, and follow up on all product complaints in a timely manner.
- Alert the Post Market QA Manager of unusual or high-risk events requiring review by Legal or Regulatory Affairs.
- Maintain order, cleanliness, equipment calibration, and Product Evaluation lab supply inventory.
- Maintain complaint files within a secured environment.
- Create tailored complaint reports for Corporate, Local Management, Regulatory, Research & Development, and other departments upon request.
- Maintain and retain complaint records in accordance with the US record retention policy.
- Maintain the Implant Registry database.
- Perform additional duties as assigned.
What We're Looking For
- Excellent verbal and written English communication skills.
- A 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 focus.
- 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.
Nice to Have
- BA/BS in a life sciences field.
- A degree in a technical or life sciences discipline.
- 0-3 years of relevant experience.
- Experience in a medical device development or manufacturing environment.
- Experience with Class II and Class III implantable medical devices.
Technical Stack
- MS Office (Word, Excel, PowerPoint)
Team & Environment
You will support senior PMS specialists and work closely with the Product Evaluation team, reporting directly to the Post Market QA Manager.
Benefits & Compensation
- Comprehensive medical, dental, and vision insurance plans.
- Company-sponsored wellness programs and mental health resources.
- Paid leave of absence for qualifying events.
- Generous paid parental leave for both birthing and non-birthing parents.
- Competitive 401(k) plan with immediate company match.
- Financial planning services.
- Corporate discount programs for goods and services.
- Generous paid time off.
- Flexible work hours and flexible work arrangement options may be available.
- Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
Coloplast is an equal opportunity employer.
