- Novo Nordisk Inc. (Plainsboro, NJ)
- … Processors and resolve issues in a timely manner Serve as Technical Complaint Processing Team's safety system manager Oversight of quality management: ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...you ready to make a difference? The Position The Manager - Technical Complaints Call Center Oversight is responsible… more
- Insmed Incorporated (NJ)
- …barriers to treatment; as well as collaboration with the Field Access Manager and Key Account Directors to monitor access challenges Therapy Initiation Coordination: ... and changes, demonstrating flexibility in working with various teams and handling diverse patient needs. Patient-Centric Approach: Demonstrate a strong focus on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …SOPs regarding adverse event reporting from post-marketing sources and clinical trials complaint handling Ensures local/affiliate SDEA templates meet both Global ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and… more
- Insmed Incorporated (NJ)
- …about combination products.You'll also: Support Post-Market Surveillance activities, including complaint handling , investigation, and root cause analysisApply ... with serious diseases. In this role, you'll be reporting to the Manager , Combination Product Development.The Insmed Summer Internship Program is designed to give… more
- ConvaTec (Greensboro, NC)
- …to FDA as part of post market compliance activities within the complaint handling system. **Responsibilities** + Processes, investigates, and monitors trending ... **About Convatec** **Pioneering trusted medical solutions to improve the lives we touch:**...received are appropriately investigated and concluded per the company's complaint handling procedure. + Tracks and evaluates… more
- Philips (Bothell, WA)
- …required with Master's Degree. + Have understanding and practice with 21 CFR 820.198 Complaint Handling , 21 CFR 803 Medical Device Reporting, and related ... ** Complaint Handling Business Expert** **In this...evaluates initial assessments of reportability, promptly escalates to the manager for further determination and necessary action, and ensures… more
- BD (Becton, Dickinson and Company) (Vernon Hills, IL)
- …+ Work with Regional Complaint Centers to resolve and address complaint handling issues. Utilization of database systems used to process complaints, ... **Job Description Summary** As directed by the Quality Manager , the Quality System Specialist III is accountable...activities comply with applicable FDA and ISO requirements for complaint handling and adverse event reporting +… more
- J&J Family of Companies (Santa Clara, CA)
- …years' experience with complaint investigations, and 10 years' experience with Medical Device Complaint handling , Post Market Surveillance and Regulatory ... & Johnson is hiring for a **Post Market Surveillance Manager - Shockwave Medical ** to join our...Functions** + Management of the assigned aspects of the Complaint Handling Process + Ensure compliance of… more
- Veterans Affairs, Veterans Health Administration (Saginaw, MI)
- Summary This internal job announcement is for a Registered Nurse - Safe Patient Handling and Mobility (SPHM) Program Manager reporting to the Chief of Education ... at the Aleda E. Lutz VA Medical Center. Responsibilities Duties include but not limited to:...but not limited to: The Registered Nurse, Safe Patient Handling and Mobility (SPHM) Program Manager (PM)… more
- Philips (Colorado Springs, CO)
- …Image Guided Therapy Devices (IGTD) quality organization by ensuring compliance of complaint handling returned device analysis processes and assessment of ... The Senior Manager -Post Market Quality plays an important role within...internal audits, aids in regulatory compliance gap closure, monitors complaint handling and Correction & Removal quality… more
- Abbott (Plano, TX)
- …the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product ... the pain continuum. Under the direction of the department manager , the Postmarket Surveillance Analyst II may perform two...analysis. Degreed applicants without medical , scientific, or complaint handling … more
- LSI Solutions (Victor, NY)
- …supporting various activities on the Regulatory Team, including administration of LSI's complaint handling system, and assisting with the procurement of domestic ... complaint subject matter expert. + Advise engineers doing complaint analysis on the complaint handling...years of administrative experience with 3+ years of experience handling medical complaints and/or medical … more
- AristaCare (Cherry Hill, NJ)
- …clean, well groomed and protected from accidents, injury and infections. The Unit Manager serves as a liaison between all other departments and personnel on the ... unit. Delegation of Authority As Unit Manager you are delegated the administrative authority, responsibility, and...+ Ensure that an adequate stock level of medications, medical supplies, equipment, etc., is maintained on premises at… 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
- International Paper (Indianapolis, IN)
- …/ questionnaires and timely complaint follow up and reports etc. The Quality Manager is responsible for completing all other tasks as assigned in support of the ... Complex Quality Manager Description: **Position Title:** Complex Quality Manager...our Quality System and will maintain an effective quality complaint / audit system to provide data to measure… more
- City Wide Facility Solutions (Chicago, IL)
- …& NORTHWEST INDIANA City Wide Facility Solutions is actively seeking a Night Manager or Contract Compliance Manager for our Franchise location in Chicago ... If you answered yes, consider this great opportunity with City Wide! Night Manager is accountable for ensuring the highest standards of quality control across all… more
- Compass Group, North America (Redmond, WA)
- …changes + Provide specific written operating procedures to unit managers, as needed ** Complaint Handling ** + With the leadership of Corporate QA, aggressively ... reports of food-related illness, food-related injury, and product defects following identified complaint handling protocols + Assist Corporate QA in facilitating… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …experience on the medical device industry with attention to complaint handling and adverse event reporting and/or post-market surveillance organization ... The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, 21CFR820, 21CFR806 and… more
- ConvaTec (Bridgewater, NJ)
- …Specialists, Engineers, Supervisors and (other manufacturing locations). External auditors, Global Complaint Handling Unit, Global CAPA Handling unit ... **About Convatec** **Pioneering trusted medical solutions to improve the lives we touch:** Convatec is a global medical products and technologies company,… more
- Hologic (Marlborough, MA)
- …other regulated industry. + Proven success in managing post-market investigations, complaint handling , and quality improvement initiatives. + Experience ... Manager , Post-Market Quality Engineering Newark, DE, United States...Canadian MDR. + Expertise in post-market quality processes, including complaint management, adverse event reporting, CAPA, and risk management.… more
