Adverse Event Reporting Specialist II, Temporary

Role Overview

• 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.
• Manage information requests as received from GHA's. Coordinate request for information and manage timelines with other departments, including engineering and quality to ensure requested information is accurately provided per required timeline.
• 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.
• Communicate with internal global subject matter experts and affiliate factories keep up to date on each countries' health authority requirements and to ensure reporting requirements and deadlines are met.
• Maintain MDR log to ensure all reportable events are captured and reported per regulation.
• Peer review MDR, Vigilance and MDPR reports prior to submission.
• Maintain adverse event files electronically to support compliance with regulatory requirements as well maintain compiled MDR files submitted on behalf of 'outside United States' (OUS) Affiliate factories.
• Perform cross-training with Complaints Specialist and others on adverse event reporting for MDR, Vigilance and MDPR.
• Attend training to enhance product and PMS&V knowledge.
• Provide reported MDR case data to Affiliate factories monthly
• 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)
• Assist with third party/regulatory audits (Customer, Notified Body, FDA)
• Monitor and remain current with internal company procedures/policies, international QS standards and federal regulations.
• 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.
• Performs other job-related duties as assigned.

Requirements

• 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.
• 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 company's policies/procedures and the applicable external standards/regulations.
• Proficiency in Microsoft Office applications as well as other Document Control software applications
• Excellent oral communication skills

Benefits

• annual bonus
• paid vacation
• paid holidays
• health, dental and vision benefits
• 401(k), with matching contributions
• tax advantage savings accounts
• legal plan
• voluntary life and AD&D insurance
• voluntary long-term disability
• short term disability
• critical illness and accident insurance
• parental leave
• personal leave
• tuition reimbursement
• travel assistance
• employee assistance program