- Arthrex (Goleta, CA)
- …and Experience: * High School Diploma or GED required. * Experience with medical device handling and processing preferred.Knowledge and Skill ... Arthrex, Inc. is a global medical device company and a leader...complaint . Join our talented team at a global medical device company focused on Helping Surgeons… more
- Arthrex (Goleta, CA)
- Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives ... for regular, full time employees.Arthrex, Inc. is a global medical device company and a leader in...complaint processes is timely and meets requirements. Create device history records for repair devices. Responsible for ensuring… more
- Teleflex (Chelmsford, MA)
- …* ISO 13485 regulation knowledge and experience with MDSAP; certification is preferred * Medical Device Complaint Handling . * Problem-solving and quality ... :10968 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to...* This position requires direct contact with an implantable device . ☐ Yes ☒ No * Other duties as… more
- Integra LifeSciences (Princeton, NJ)
- …ISO 13485 compliance and quality assurance. *Proficient understanding of medical device regulations which include complaint handling , adverse event ... and managing Integra's Global Post Market Surveillance Program. This includes Complaint Handling , Adverse Event Reporting, Health Hazard Evaluations (HHEs),… more
- Vyaire Medical (Oklahoma City, OK)
- …of corporate and service department procedures and policies, including customer complaint handling and medical device reporting. + Provide accurate and ... Medical Device Field Service Technician II... Medical Device Field Service Technician II - Ventilation **Help...training required and 2+ years of electro-mechanical, electronic, IT, medical device repair experience required **or** +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …TrackWise) + Extensive knowledge of FDA Quality Systems Regulations 21 CFR Part 820, Medical Device Reporting 21 CFR 803, Report of Corrections and Removals 21 ... **Job Description Summary** The Manager, Complaint Management role is responsible for investigational activities...Regulations for Medical Devices, such as EU Medical Device Regulation (MDR), Canada SOR/98-282 … more
- Boehringer Ingelheim (Ridgefield, CT)
- … meetings as the SME with the primary responsibility of process knowledge, complaint handling , training, and driving improvements. The responsibility of this ... position includes but are not limited to interaction with medical and non- medical contact centers, quality and...appropriate regulations; applies knowledge to ensure accurate and timely complaint handling . + Assists in all documentation… more
- DEKA Research & Development (Manchester, NH)
- …opening for a Product Complaint Manager to work in a dynamic Medical Device Research and Development environment. The position reports to the Program ... years experience in post market surveillance/ complaint handling in a regulated environment; management and medical... handling in a regulated environment; management and medical device experience preferred. Additional experience and… more
- US Tech Solutions (North Chicago, IL)
- …**KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:** + Initiate, investigate, and maintain complaint files following complaint handling regulation 21 CFR ... according to procedures. + Assess incoming documentation, including clinical forms and medical information, for complaint data and ascertain compliance to… more
- Philips (Orlando, FL)
- …Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally. + Completes initial assessment of ... to manager to determine action, when necessary. + Analyzes complaint data, gathers additional data as needed, and partners...Bachelor's degree with 1+ years of experience in a medical device or regulated industry. + Your… more
- ICU Medical (CA)
- …ICU Medical Product, that I will communicate this information to the appropriate ICU Medical safety or complaint handling group in a timely manner. ICU ... *Position Summary*// The Device Sales Specialist is responsible for meeting and...products in the market and how to position ICU Medical 's Infusion Systems offerings against them clinically. Be the… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …knowledge of medical device quality systems, FDA regulations relative to complaint handling and medical device reporting requirements including ... Analyst II is responsible for supporting medical device adverse event reporting within the complaint handling process. This position is responsible for… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …or Bachelor of Science degree with 5 or more years of medical device experience including adverse event reporting. + Complaint Handling / Customer Service ... member, you will be responsible for the review of medical device global complaints and coordinate the...requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485,… more
- Abbott (Plymouth, MN)
- …2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related ... You'll Work On** + Postmarket Surveillance Analyst may perform two different functions within complaint handling . One role is that of complaint investigation… more
- Terumo Medical Corporation (Elkton, MD)
- …a quality, customer complaint investigation/resolution, or clinical experience in medical device industry (disposable devices). + Strongly prefer Clinical ... of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in...of critical issues and customer concerns. 12. Maintenance of complaint handling site procedures. 13. Gathers and… more
- Bausch + Lomb (Rochester, NY)
- …of communication between manufacturers, distributors and competent authorities for all medical device complaint related activities, including assistance ... **Responsiblities:** - Provide understanding, leading analysis and management of information regarding medical device complaint events and/or adverse events,… more
- Bausch + Lomb (Clearwater, FL)
- …of communication between manufacturer, distributors and competent authorities for all medical device complaint related activities, including assistance ... RESPONSIBILITIES + Provide understanding, leading analysis and management of information regarding medical device complaint events and/or adverse events,… more
- Abbott (Alameda, CA)
- …reports to the rest of world for the division's products. Is proficient with medical event reporting and complaint handling policies and procedures. Manages ... medical event reporting within the framework of the complaint handling system. + Utilizes good judgment...handling (21CFR820.198). + Minimum 5 years In the medical device field. + Minimum 3 years… more
- Envista Holdings Corporation (Quakertown, PA)
- …operations, regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to ... The **Quality Assurance Supervisor** is responsible for leading the Complaint Handling /Post-Market Surveillance (PMS) team to provide...+ Five or more years of experience in the Medical Device industry. + At least two… more
- Abbott (Alameda, CA)
- …and scientists. **The Opportunity** Responsible for timely review, documentation and filing of Medical Device Reports to the FDA (US), Medical Problem ... Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest...with regulations. + Document filing decision rationale in the Complaint Handling System. + Ensure timely submission… more
