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This position is responsible to assist the Post Market Surveillance and Vigilance group (PMS&V) with Medical Device Reporting (MDR) to US and global health authorities (GHA) such as FDA, HC, MHRA, etc.  The Adverse Event Reporting Team is responsible with implementation of best practices to optimize quality, efficiency & productivity in systems throughout TMC and other Terumo facilities by MDR reporting for other Terumo Corporation entities.  Responsible for assisting with the Audits; Tracking and reporting progress of specific Quality System indicators for management review; Recommendation and implementation of appropriate corrective/ preventive action improvements and, when possible, cost reductions, through the review & writing of new or revised procedures; Assisting with third party/regulatory audits and administration of the Adverse Event Reporting program.

1.    Review complaints to confirm reportability meets Regulatory reporting requirements.  Provide comments and suggestions as needed and follow-up with team members on request for additional information to ensure accurate and complete submissions.
2.    Manage information requests as received from GHAAAAs. Coordinate request for information and manage timelines with other departments, including engineering and quality to ensure requested information is accurately provided per required timeline.
3.    Continuously reviewing complaints status and updating file with progress and information findings to ensure all required information is submitted to the appropriate regulatory agency in a timely manner.
4.    Communicate with internal global subject matter experts and affiliate factories keep up to date on each countriesAAA health authority requirements and to ensure reporting requirements and deadlines are met. 
5.    Maintain MDR log to ensure all reportable events are captured and reported per regulation.
6.    Peer review MDR, Vigilance and MDPR reports prior to submission.
7.    Maintain adverse event files electronically to support compliance with regulatory requirements as well maintain compiled MDR files submitted on behalf of AAAoutside United StatesAAA (OUS) Affiliate factories.
 

8.    Perform cross-training with Complaints Specialist and others on adverse event reporting for MDR, Vigilance and MDPR. 
9.    Attend training to enhance product and PMS&V knowledge.
10.    Provide reported MDR case data to Affiliate factories monthly 
11.    Review & draft proposals to implement changes to the Quality System procedures/forms as needed to maintain compliance, improve effectiveness, & efficiency. (participate in process improvements throughout scope of role)
12.    Assist with third party/regulatory audits (Customer, Notified Body, FDA) 
13.    Monitor and remain current with internal company procedures/policies, international QS standards and federal regulations. (combine bullet 1 here)
14.    Assist the Manager, Product Complaints with tasks such as FDA correspondence, occasional customer complaint calls and maintaining communication with all domestic and overseas Terumo facilities.  All these duties must be performed in such a manner as to assure that strict confidentiality is maintained.
15.    Performs other job-related duties as assigned.
 

Internal Contacts:  Complaints Specialists and Complaints Engineers with regards to complaint investigations of product manufactured by TMC.  TMC/TCVS/TC affiliates AAA correspondence, complaint investigations, etc.

External Contacts:  FDA auditors AAA correspondence regarding audits and medical device reporting; Health Canada AAA correspondence regarding Canadian Medical Device Reporting, correspondence regarding customers AAA promote customer satisfaction and assist QA with receipt and processing of complaints.

• Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, , ISO 13485, and MDD 93/42/EEC
• Ability to understanding and follow the companyAAAs policies/procedures and the applicable external standards/regulations.  Failure to do so can result in failures to meet compliance requirements.
• Proficiency in Microsoft Office applications as well as other Document Control software applications
• Excellent oral communication skills

Bachelors Degree preferably in health, regulatory and a minimum of 3 years experience or

Associated Degree with five years work experience in quality assurance within a regulated industry preferred; or combination of High School degree or equivalent plus extensive specific relevant experience in medical device or pharma industry.