- Olympus Corporation of the Americas (Westborough, MA)
- …on communication on responses. The individual will have experience as the site MDR /Regulatory Body contact. **Job Duties** + Authors and manages the development of ... Quality initiatives and programs throughout the Global organization, as required. + Site MDR /Regulatory Body Contact. + Participates in the review of CAPAs and CAPA… more
- Proficio, Inc. (Irvine, CA)
- …an award-winning managed detection and response (https://www.proficio.com/managed-detection-and-response-service/) ( MDR ) services provider. We provide 24/7 security ... were promoted from within. Summary: Proficio is looking for a Growth Marketing Manager to drive our field and digital marketing efforts for our managed cyber… more
- Robert Half Technology (Redmond, WA)
- …We are offering a long-term contract employment opportunity for an Associate Project Manager in Redmond, Washington. As part of the team, you will employ project ... projects, independently with minimal supervision. Job Title: Associate Project Manager , Enterprise PMO Job Type: Contract position Location: Hybrid -… more
- BlueVoyant (TX)
- Channel Account Manager - US Location: The ideal hire will be located in Texas or West Coast and can travel as needed within the region. BlueVoyant is seeking an ... experienced relationship focused Channel Account Manager to join the team working closely with existing...Experience supporting the enablement & growth of a channel partner sales team to help them effectively articulate and… more
- Hologic (San Diego, CA)
- Sr. Manager Supplier Quality Engineering - San Diego, CA San Diego, CA, United States **The Supplier Quality Manager ensures suppliers continuously improve by ... improvement tools. + Prioritize suppliers for management using a risk-based approach. + Partner with Supply Chain to address delivery issues and claims recovery. +… more
- Philips (Plymouth, MN)
- **R&D Program Manager - Medical Device NPD (Plymouth, MN)** We are seeking a highly motivated and experienced Program Manager with a background in managing ... regulatory and quality standards (eg, FDA, ISO 13485, EU MDR ). Proficiency with project management tools (eg, MS Project,...including spouses and other family members, marital or domestic partner status, or any other category protected by federal,… more
- System One (Quakertown, PA)
- Title: Quality Management System Manager Location: Quakertown (On-site) Schedule: M-F 8 am-5 pm Type: Direct/Permanent Target Salary Range: $145,000 to $160,000 + ... We are looking for a passionate and results-driven Quality Management Systems Manager to lead our CAPA processes, manage audits, and collaborate with regulatory… more
- J&J Family of Companies (Danvers, MA)
- Abiomed Inc. is recruiting for a Commercial Quality Service and Repair Manager in Danvers, MA, USA. At Johnson & Johnson, we believe health is everything. Our ... Must have strong collaboration and influence management skills to partner effectively across functions and operating units. + Strong...803; 806; 807; 820; 821; 830; 860 + EU MDR 2017/745 & Directive EEC/93/42 + MDSAP Other: +… more
- Philips (Cambridge, MA)
- **QMS Manager ** **In this role you** Maintains a compliant, lean and effective MS/QMS. Partners across the business to continually improve and standardize SRC's ... 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745. + Experienced Engineer with proven success within teams and… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. Position Summary: The Group Engineering Manager will be responsible for the creation and productive functioning of the ... all Quality Compliance activities for products within department including complaint, CAPA, MDR , NCMR, and all relevant compliance activities + Development of sound… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Sr. Manager of Regulatory Affairs, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and ... to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU- MDR ) + Support the monitoring and interpreting of current and new regulatory… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …detection. + Demonstrates knowledge and experience working with various regulations (HIPPA, EU- MDR , FDA 21 CFR Part 803, 806, 820), various standards (GCP, ISO ... 13485, ISO 14971), regulatory filings (FDA IDE, 510K, EU- MDR CERs, SSCP, PMCFs, PSURs), Corrective Actions - Preventative Actions (CAPAs), Health Hazard Assessment &… more
- Philips (Bothell, WA)
- …all key regulatory agencies for product safety and quality (eg: US FDA, EU MDR , TGA, MHLW, NMPA, etc.). Develop and maintain an effective working relationship with ... requirements meet global quality and regulation requirements. + Lead, collaborate and partner with Site Quality leaders, Business MT, Philips Central teams, Markets… more
- Terumo Medical Corporation (Somerset, NJ)
- …monitoring for all new and revised external regulations and standards. + Partner with Quality Compliance Process Manager to establish time-bound product ... Summary** The Senior Quality Compliance Engineer will work with the Senior Manager of Quality Compliance to ensure Terumo Medical Corporation is achieving compliance… more
- Atlantic Health System (Pompton Plains, NJ)
- …of patients. Assures performance and regulatory standards are met. Collaborates with manager regarding need for staff disciplinary action. Assists in the evaluation, ... of practice. Provides skilled, concrete resource to staff. Attends MDR with staff. Initiates conferences to assure effective communication....discharge plan. 03. Acts as a resource to the manager in the daily management of the dept. Manages… more
- Lilly (Indianapolis, IN)
- …of US GILTI and country-by-country reporting to optimize the processes. + Partner with Corporate Financial Reporting on the requirements for local country US ... of all BEPS compliance obligations globally, including anti-hybrid, tax haven, MDR , and other obligations, ensuring compliance and recommending strategic changes for… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …limited to; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 ( MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC ... all regulatory and quality guidelines needed + Demonstrate a strong "business partner " approach and attitude providing creative and innovative solutions that meet… more
- Olympus Corporation of the Americas (Westborough, MA)
- …in creating submission materials for various regulatory domains including FDA and EU- MDR . **Job Duties** + Advise SW development teams on Software development ... safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early… more
- Olympus Corporation of the Americas (Westborough, MA)
- …creating submission materials for various regulatory domains including FDA, PMDA, and EU- MDR . **Job Duties** + Advise SW development teams on Software development ... safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …with applicable regulatory requirements, including but not limited to US FDA, EU MDD/ MDR , ISO 13485, Health Canada, MHLW, ANVISA, and TGA. + Experience in supporting ... safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early… more