Adverse Event Reporting Spec II, Temporary (6 months)

Job description

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. Join us and help shape wherever we go next! Advancing healthcare with heart Job Summary 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. Job Details/Responsibilities 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 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. 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 countries’ 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 “outside United States” (OUS) Affiliate factories. Job Responsibilities (continued) 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 – correspondence, complaint investigations, etc. External Contacts: FDA auditors – correspondence regarding audits and medical device reporting; Health Canada – correspondence regarding Canadian Medical Device Reporting, correspondence regarding customers – promote customer satisfaction and assist QA with receipt and processing of complaints . Knowledge, Skills and Abilities (KSA) 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. 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 Qualifications/ Background Experiences 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. It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: 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, and an employee assistance program. The hourly rate is $35/hour - $43/hour based on experience.