Job Information
Epredia Post Market Surveillance Specialist in Shanghai, China
Epredia, a global leader in providing solutions for cancer diagnostics, is dedicated to improving lives by enabling our customers to achieve diagnostic excellence. We’re growing quickly and constantly expanding our team. Find a rewarding career with a diverse group of individuals that share a passion to do work that matters and positively impacts patient lives.
Position Summary
Post-Market Surveillance (PMS) specialist bears responsibility to handle customer complaints filed by domestic Chinese customers. Confirmed via essential risk evaluation, PMS specialist shall report such case as Adverse Events to National Medical Products Administration (NMPA)/CFDA. Periodic Risk Evaluation Report (PRER) shall be submitted annually to NMPA/CFDA for registered products. PMS specialist will need to manage routine account maintenance activities of the online reporting system. RA specialist owns overall registration strategy for medical device from all Epredia factories to be sold into China market. This position is key to support the release of product labels, user manuals and other necessary technical documents, in parallel to coordinate sample testing. One shall seek success in a whole process from product registration till final launching in China market.About Epredia
Improving lives by enabling better cancer diagnostics. Epredia offers a complete line of cancer diagnostic instruments and consumables from specimen collection to diagnosis. Epredia`s collaborative team of employees are delivering critical answers and strive to provide Pathology labs a more efficient, safe and productive environment.How will you make an impact?
PMS specialist is essentially in responsible for complaint handling onto all Epredia products sold within China market, thriving to achieve a comprehensive overview reflecting how domestic Chinese customers value the Epredia products. Towards all medical and non-medical device, a proactive and robust feedback handling mechanism is crucial to the improvement of Epredia product quality, equivalently as crucial as to the compliance of China’s laws and regulations. RA specialist takes critical responsibility to step by step ensure lawful registration of Epredia products into China markets. Without which our Epredia products will not be granted for sales or distribution in China. Registration status in association with each product is subject to RA specialist for monitoring and maintenance at routine manner, ultimately to sustain continuous business success in domestic China market.What will you do?
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.
Document and monitor complaint trending, and report to Epredia Quality & Commercial periodically.
Routine account maintenance of all agent and product license information in online reporting system.
Submit PRER annually for all medical device registered to NMPA/CFDA.
Support local quality team to handle other product quality issues occurred in Post-Market phase.
Act as contact window to NMPA and participate regular training sessions held by NMPA/CFDA.
Support RA upon global registration activities upon importing medical device from oversea sites.
How will you get here?
Mandatory Requirements
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.
Ability to monitor and report complaint trending with visualized presentation.
Preferred Requirements
Business or regulatory-related background
Experience in Post-Market Surveillance among medical device industry
Experience in China NMPA registration process, preferably of anatomy pathology industry.
Experience in medical device manufacturing industry.
Good practice of Excel, Word and PowerPoint.
Fair knowledge in GMP/GSP or QMS aspects.
Strong English communication upon document writings and oral presentation.
YOUR APPLICATION
Epredia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.
TO ALL RECRUITMENT AGENCIES
Epredia does not accept unsolicited third party resumes.
Epredia is an Equal Opportunity Employer.
Our Journey. Epredia is on a journey to create an inclusive environment where we celebrate multiple approaches and points of view. Our goal is to attract, develop and retain the best and brightest from all walks of life and backgrounds. Your candidacy will be reviewed regardless of race, religion, gender, sexual orientation, national origin, disability, age or veteran status.
At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.