- Edwards Lifesciences (Sacramento, CA)
- ** Manager , Clinical Science/Medical Writing, Transcatheter Mitral and Tricuspid Therapies (TMTT)** Edwards Lifesciences is the global leader in patient-focused ... opportunity for an exceptional Clinical Scientist/Medical Writing professional (internally called Manager , Medical Affairs) to join a team that is boldly designing… more
- Envista Holdings Corporation (Quakertown, PA)
- …professional relationships across the organization. **POSITION SUMMARY** The **Quality Assurance Manager ** (QA Manager ) is responsible for leading the Quality ... the work of staff in this area. The QA Manager oversees post-market data for product and process improvement...+ Knowledge of FDA regulations, ISO 13485 MDSAP, EU MDR + Proficient use of computers, MS-Office (Word, PowerPoint,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Manager , Clinical Data Standards is responsible for the development and sustainability ... also some of the requirements of this role. The Manager , Clinical Data Standards should be a subject matter...participate in the committees of the Clinical Data Standards, partner with functional area stewards, organize standards topics to… more
- 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
- Envista Holdings Corporation (Pomona, CA)
- **Job Description:** Under the direction of the Senior QA Manager , this position is responsible for ensuring that core functions of Quality Assurance are ... This involves assuring quality standards (FDA, ISO, CMDCAS, MDD, MDR , MDSAP and Canadian Medical Device requirements) are with...trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its… more
- Envista Holdings Corporation (Brea, CA)
- …assembling CE Technical files and final review of deliverables for MDR regulatory compliance. Also tracks marketing clearances/approvals, licenses, and applications ... and new products. + Independently prepare and maintain EU MDR technical files, Australian and New Zealand registrations. +...monthly reports on status of current issues to the Manager of Regulatory Affairs. + Work on ad-hoc projects… more
- Teleflex (MA)
- Sr. Regulatory Affairs Manager - Product Management **Date:** Oct 25, 2024 **Location:** Remote, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% ... lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with...a difference in patients' lives. **Position Summary** The Senior Manager , Regulatory Affairs is an experienced leadership position with… more
- Teleflex (NC)
- Manager , Clinical Data Management **Date:** Nov 8, 2024 **Location:** Remote, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** :11087 ... and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas… more
- Medtronic (Los Angeles, CA)
- …their diabetes easier and more connected. In this exciting role as an Engineering Manager , you will have responsibility for managing a team of hardware and process ... Collaborate with R&D, system engineering, our product management organization and partner engineering teams in making product design decisions. + Drive establishment… more
- 3M (CA)
- …where you can collaborate with other curious, creative 3Mers. 3M is seeking a Tax Manager for its Finance Division located in Canada. The Impact You'll Make in this ... RoleAs the Canada Tax Manager , you will have the opportunity to tap into...building strong cross-functional relationships and operate as a business partner and not merely an in-house tax advisor +… 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
- Olympus Corporation of the Americas (Westborough, MA)
- …with applicable regulatory requirements, including but not limited to US FDA, EU MDD/ MDR , ISO 13485, Health Canada, MHLW, ANVISA, and TGA. + Experience working in ... 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
- 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
- Teleflex (Mansfield, MA)
- …and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas ... regulatory and quality compliance initiatives. Under guidance of the Quality Manager and other Teleflex global resources, this position supports adherence to… 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
- 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
- Sleep Number (Minneapolis, MN)
- …party security operations staff (responsible for level 1-2) and account manager (s). Ensure KPIs are maintained . Escalate non-compliance to contractual agreement(s). ... on the status of cybersecurity operations and incidents. + Partner closely with security engineers and other technology teams...experience in managing an outside managed service provider (eg, MDR , SOC as service) to ensure KPIs and service… more
- Medtronic (Mounds View, MN)
- …manuscripts. Work will generally be self-directed but will be reviewed by the Manager at key time points. The Structural Heart and Aortic integrated operating unit ... regulatory review and approval of the experimental therapies. + Partner in trial design and in establishing standards for...guidelines for clinical trials and medical devices (eg, ISO, MDD/ MDR ) + High level of knowledge of clinical trial… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …inspections, industry trends and the external regulatory environment. Acts as Audit Program Manager + Direct management and oversight of BD quality audit program and ... Quality Auditor/ISO Lead Auditor Certified, Certified Quality Engineer, Certified Manager of Quality/Organizational Excellence or Exemplar Global ISO 13485 Lead… more
- Medtronic (Mounds View, MN)
- …with Key Opinion Leaders (KOLs) and internal business partners. Partner with National Principal Investigators, clinical site investigators and physician ... medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR , etc.) as needed + Experience in Research and...computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more