Complaint Specialist MDR and Recalls

Job Title:

Complaint Specialist MDR and Recalls  

Responsibility:

·   Prepare agency reports as related to field actions and reporting according to the company’s procedure.

·   Organize and provide primary support to field correction activities

·   Perform required tasks to facilitate customer mailings by using internal and third-party resources

·   Communicate with other GBO sites and with regulatory professionals as per company's procedures

·   Interface with the FDA and other regulatory bodies in a matter of recall and reporting (MDR, MPR, Vigilance).

·   Ensure mandatory corrections, removals, and recalls are managed effectively and efficiently

·   Administer and organize device reporting for the US and Canada

·   Establishes procedures in regards to recalls and reporting.

·   Participate in and organize recall activities.

·   Establish recall strategies, including recall letters, reports, and effectiveness checks.

·   Organize and process complaints evaluations.

·   Formulate and finalize QA statements for complaints.

·   Perform trending analysis for complaints.

·   Other duties as assigned.

Authority:

 

·   Communicates with heads of departments and process owners in regard to complaints, recalls, and reportings.

·   Communicates with the FDA and other regulatory agencies in regards to recall and MDR.

·   Communicates with other GBO facilities regarding complaints, reporting, and recalls.

·   Organize and coordinates recall and MDR meetings.

·   Calls meetings in regards to recalls, reportings, and complaints.    

Job Requirements:

 

·   College degree in life engineering or science field preferable Medical Technology preferred.

·   Experiences with Quality Management systems like ISO 13485 or GMP.

·   Experience in Quality Assurance functions and Quality Compliance functions. Experience with 21 CFFR 803 and or 806 preferred.

·   Must have very good communication and medical writing skills.

·   Proficient computer skills in Microsoft Excel and Word.

·   Must pass the pre-employment examination, qualification test.

Physical Requirements:

·   Must be able to sit, stand and walk for 8 ½  hours.

·   Must be able to lift 50 lbs.

·   Must have an appropriate vision to perform detailed inspections as outlined in SOPs or TPs.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, sex, sexual orientation, gender identity, genetic information, age national origin, veteran status, physical or mental disability or any other characteristics protected under applicable federal, state or local law.

 

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