Post Market Surveillance Analyst
In this role, you have the opportunity to
Coordinate, maintain, and enhance the complaint handling program, including complaint trend analysis, returned product analysis, clinical complaints, and regulatory reporting (such as MDRs, incident reports, etc.)
You are responsible for
- Coordinate, and Maintain Complaint Handling Program and Adverse Event Reporting
- Receive, review, and document complaint information timely and accurately
- Establish a complaint report file for each individual complaint, organize and maintain all complaint records and monitor all complaint records to ensure timely closure.
- Coordinate the process for complaint investigations and resolution, including returned goods evaluations, review of manufacturing records, decontamination and inspection of samples, evaluations of raw materials, manufacturing processes and DHR review, and testing as appropriate.
- Communicate with sales representatives, engineers, hospital risk management, physicians, lab personnel, etc. in order to obtain the information required in order to complete the complaint form and adverse event reports
- Maintain the complaint log timely and accurately to ensure inspection readiness at all times.
- Establish complaint metrics and generate trend analysis for quarterly metric reviews and provide feedback to the management team.
- Provide guidance to all employees for handling complaint information.
- Write, revise SOPs, WIs, and FRMs needed to maintain a complaint handling program
- Prepare initial and supplemental MDRs for regulatory reporting to FDA in a timely manner. Ensure reporting of MDRs to FDA within 30 days.
- Prepare initial and final reports for reporting to Competent Authorities and Health Canada in a timely manner.
- Notify the Authorized Rep by providing a copy of the vigilance reports
- Notify the Notified Body by entering the vigilance information directly onto their website
- Inform the appropriate Japanese distributor for reporting to PMDA
- Inform the appropriate South Korean distributor for reporting to MFDS
- Prepare customer letters or send emails to sales representatives with the results of the investigation.
- Perform back-up QE tasks and investigations, as needed.
- Train teammates on complaint handling processes (initiation, investigation, reportability, and closure)
- Actively communicate with external suppliers, regulatory agencies, distributors, departments, and sales representatives to ensure timely closure of complaint files.
- Follow current policies and procedures to ensure compliance with all US and international regulations relating to complaint reporting
- Perform complaint database searches and provide complaint data input to annual reports, submissions, corrective actions or as requested for engineering sales/marketing, etc.
You are a part of
Our Quality Systems Post-Market Surveillance team working with, Quality, Engineering, and Clinical departments to complete complaint investigations.
To succeed in this role, you should have the following skills and experience
- BS in Life Sciences or Engineering degree (preferred) or equivalent related experience and/or training in the medical device industry
- Minimum of two years experience working in complaint handling at a medical device organization
- Related experience in a medical device manufacturing organization
- Experience with FDA requirements, knowledge of regulations such as GLP, GMP, ISO 13485, and other international regulatory requirements. Working knowledge of Japanese MHLW Ministerial Ordinance 169.
- Proficiency in MS Word, Excel, PowerPoint, and Access
- Excellent organizational and prioritization skills with ability to manage several tasks simultaneously; Must be able to work independently and prioritize responsibilities to complete tasks on schedule
- Must have initiative, motivation, good judgement, ability to manage multiple tasks with frequent interruptions, and high attention to detail and accuracy.
- Strong work ethics
- Independent problem solver with excellent written communication skills.
- High initiative in a fast-paced environment
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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