EU Post Market Surveillance Specialist

Job description

Primary Function of Position

The Post Market Surveillance Specialist supports the Regulatory Department by reviewing, evaluating, and performing follow up activities on all product complaints, determining if they require vigilance reporting and identifying supporting data.

Roles and Responsibilities

Main activities Evaluates incoming complaint information and maintains the records in the electronic database as per company procedures and processes. Works closely with Customer Service to support the product return process as it relates to complaints. Processes, records, and closes complaint-handling activities in a timely manner. Conducts follow-up investigations with internal resources, field personnel and/or customer as appropriate to gather additional information for reported events and assist in data collection for trending purposes.

Determines reportability of complaints per regulatory reporting requirements. Acts as an interface between EMEIA customer support team, Regulatory Post Market Surveillance team in US and European customers, including distributors. Additional activities Evaluates and reports device malfunctions involving company products to the European regulatory agencies. Collect, trend, and escalate data related to Post Market Surveillance.

Assists and supports other employees, teams, and field personnel as necessary. Other regulatory tasks and projects may be assigned as necessary.

Qualifications

Qualifications

Required Knowledge, Skills, and Experience: Knowledge / understanding of the European Medical Device Regulation (EU) 2017/745 (EU MDR), applicable MDCG guidance, UK Medical Devices Regulations 2002 (as amended), including applicable MHRA vigilance requirements, and the Swiss Medical Devices Ordinance (MedDO), including applicable Swissmedic vigilance requirements. Understanding of quality records requirements and how they apply to complaint files and post-market surveillance reports.

A Bachelor’s degree or Swiss CFC (Health Sciences preferred). 6 months – 2 years of experience in complaint handling for medical devices. Ability to handle multiple tasks, prioritize and schedule work to meet business needs. Demonstrate organizational and planning skills, including being action-oriented, maintaining a sense of urgency, and driving results. Demonstrate good communication skills over the phone, in person and in writing.

Demonstrate good interpersonal skills, the ability to work with others in an international team environment, and effective interactions in cross-departmental teams. Ability to guide customers in providing key relevant data for case management. Attention to detail, with emphasis on accuracy and completeness. Fluent in written and spoken English, Spanish and Portuguese. General computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook).

Basic knowledge of US FDA 21 CFR Parts 803 and 806, and 21 CFR Part 820 (Quality Management System Regulation – QMSR), would be a plus. Experience with software such as TrackWise, ERP/CRM (e.g., SAP) or Salesforce is a plus.