Be a part of a global team where what we do matters! At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding – both personally and professionally – because what we do matters.
We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation.
People – We win as a team.
Customer – We deliver customer-centric solutions.
Continuous Learning – We learn and always aim to be better.
Innovation – We innovate every day.
Results – Results matter for all of us.
Job Title：PMS Specialist
Position Summary:
Post-Market Surveillance (PMS) specialist bears responsibility to handle customer complaints filed by customers.
Key Responsibilities:
- Handle external complaints arrived from NMPA/CFDA online reporting system.
- Communicate actively with relevant parties to acquire necessary information related to complaints.
- Report Adverse Event via online reporting system, once the complaint is confirmed an adverse case. Submit the investigation reports into online reporting system for all adverse events as required.
- Document and monitor complaint trending, and report to Epredia Quality team periodically.
- Create and update PMS report as required.
Minimum Requirements/Qualifications:
- Minimum 2-year experience in Post-Market Surveillance among medical device industry.
- Strong knowledge of NMPA/CFDA laws and regulations in scope of PMS activities.
- Strong awareness on medical device specs, failure modes and possible negative impacts.
- Proficient in collecting complaint-related facts for compilation, in assisting failure analysis.
- Sufficient communication skills to feedback to manufacturing sites in technical language.
TO ALL RECRUITMENT AGENCIES: Epredia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings the best people together and leverages their varying backgrounds, ideas, and points of view to invent on behalf of all customers. We are committed to equal employment opportunity for all individuals, without regard to race, color, national origin, ancestry, sex, age, religion, physical or mental disability, medical condition, veteran status, marital status, pregnancy, sexual orientation, gender identity, genetic information or any other protected classes which may exist under applicable federal, state or local law.
Skills Required
- Minimum 2-year experience in Post-Market Surveillance in the medical device industry.
- Strong knowledge of NMPA/CFDA laws and regulations relevant to PMS activities.
- Strong awareness of medical device specifications, failure modes, and potential negative impacts.
- Proficient in collecting complaint-related facts and assisting failure analysis.
- Sufficient technical communication skills to provide feedback to manufacturing sites.
What We Do
Every second of every hour of every day, 44 of our products are employed in the battle against cancer. Customers put their trust in Epredia over a billion times every year. Epredia was established in July 2019 through an acquisition by PHC Group from Thermo Fisher Scientific. Powered by trusted brands such as Shandon, Microm, Menzel Gläser and Richard-Allan Scientific, Epredia has a wide breadth of solutions that have and will continue to transform the anatomical pathology market. Today, we’re a global precision cancer diagnostics company working to improve patient outcomes by providing groundbreaking technologies. Since our humble beginnings in 1937, every product developed has been impacted by generations of employees who are committed to improving lives by enabling pathologists through enhancing precision cancer diagnostics. Find out how you can improve lives while advancing your career at #Epredia by visiting epredia.com/careers. #WhatWeDoMatters
