Post Market Surveillance Specialist Job Details | Coloplast A/S

Coloplast • Minneapolis, MN

46d

About The Position

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.

Requirements

• 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
• 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.

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

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, and corporate discount programs for goods and services.
• Generous paid time off, flexible work hours, and 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 5,001-10,000 employees