Post-Market Surveillance Specialist — Flexible Hours

Coloplast; Minneapolis (MN); Hybride; USD 81 000 - 121 000; Plein temps

Résumé du poste

Coloplast in Minnesota is seeking a Post Market Surveillance support role within Interventional Urology. This position contributes to regulatory compliance by handling post-market activities and assisting investigations of customer complaints.

You will collaborate with Medical Device Quality and Regulatory teams, coordinate with suppliers, and maintain complaint records and the Implant Registry database, ensuring timely responses and accurate reporting.

Qualifications

• BA/BS in a life sciences field is desired.
• Degree in a technical or life sciences discipline is desired.
• 0-3 years of experience.
• Experience in a medical device development or manufacturing environment is desired.
• Experience with Class II and Class III implantable medical devices is desired.

Responsabilités

• Receives and processes customer complaints per FDA/ISO 13485.
• Contacts hospitals or doctors to request returns and information.
• Coordinates evaluation with outside suppliers and documents findings.
• Supports senior PMS specialists in investigations.
• Writes correspondence to physicians about results.
• Supports closure of complaint files.
• Takes initiative to respond and resolve complaints promptly.
• Alerts QA Manager of high-risk events.
• Maintains complaint files and PE lab inventory.
• Creates tailored complaint reports for multiple departments.
• Maintains Implant Registry database.
• Other duties as assigned.

Connaissances

English communication

FDA regulations

Quality systems

Regulatory affairs

Detail oriented

MS Office

Formation

BA/BS in life sciences

Technical/Life sciences degree

Description du poste

Select how often (in days) to receive an alert:

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

• BA/BS in a life sciences field is desired
• Degree in a technical or life sciences discipline is desired
• 0-3 years of experience
• Experience in a medical device development or manufacturing environment is desired
• Experience with Class II and Class III implantable medical devices is 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 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.

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:

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, 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.
• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: 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.
• Competitive Compensation: The compensation range for this position is $80,740 - $121,110. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

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.

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.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark