*Hi,*
*Hope You are doing Well..* *Please let me know your Feedback….* Position: *Associate- Medical Devices Reporting* Location : Bridgewater Confirmed Start date : Dec 15th *Job Description:** Medical Devices Reporting Associate* *Position Title* *Associate- Medical Devices Reporting* *Support Process* *Medical Devices Reporting* *Responsibilities:* · Knowledge of Medical Device Reporting process. · Management of Medical Device and complaints/ adverse events and supervise Medical Device Reporting in Regulatory Affairs. · Support incoming complaints generated globally for the purpose of determining regulatory reportability in compliance with 21 CFR 803 and to ensure timely submission of reports to the FDA. · Ensure that case information is entered in Form 3500 or other MedWatch reports and that source documents are posted in a timely manner within the FDA/Regulatory timelines. · Responsible for data entry, data coding, and maintain the completeness and accuracy of data for MDR reporting. · Responsible for performing data review, duplicate checks, and clean-up processes. · Perform consistent coding of diseases, adverse events, and medications according to the project-specific coding conventions in the Safety Database assessing reportability of MDR. *Requirement:* Ø *Academic Qualification/Certifications: * · Life Science graduate in Microbiology/Pharmacy/ Biomedical Science, or similar clinical discipline. · Experience in handling of data for Medical Devices Reports (Complaint Evaluation / Medical Device Reporting / Safety / Compliance). · Experience in Regulatory submissions, e-submission training, medical interpreting, and medical terminology. · Minimum 4 years of experience. · User experience AssurX CATSWeb preferred. Ø *Competencies:* · Assist with multiple data collections and analyses for FDA responses · Self-motivated and achievement driven. · Flexible with respect to shifts. · Effective communication skills (verbal and written) · Ability and willingness to make decisions in a fast paced environment with attention to detail. *Looking forward to have a fruitful Business relationship with you and your company!!* *I apologize if this mail created any inconvenience to you..* *Thanks & Regards.....* *Arif Khan* *Technical Recruiter.* *[image: LOGO]* *[email protected] <[email protected]>* *GTalk: [email protected] <[email protected]>* *Centraprise Corp Edison , New Jersey.* *3 Ethel Rd,Suite # 304. Direct: 6093570797 Ex : 459* *Fax :(732) 626 6289* *Minority Owned (MBE) Certified* -- You received this message because you are subscribed to the Google Groups "Exact Match" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/exact-match. For more options, visit https://groups.google.com/d/optout.
