- Beckman Coulter Diagnostics (Brea, CA)
- …experience in:Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (eg CQM, CQE, CQA, RAC, ... GPO will also take on the role of CAPA Manager of the Global CAPA Review Board (CRB). This...responses and requests for information to FDA, MDSAP Notified Body and other Regulatory Bodies.Utilize Danaher Business… more
- AbbVie (Pleasanton, CA)
- …or BA in engineering, biology or other health sciences; plus five-year experience in regulatory affairs . + At least three-year experience working in a medical ... 1. Submissions, development and lifecycle maintenance * Plans and prepares complex regulatory documents for US and ROW product approvals with minimum supervision. *… more
- Hologic (San Diego, CA)
- … Affairs team here in San Diego, and are looking for a Regulatory Affairs Manager , responsible for on-market regulatory activities associated ... Manager , Regulatory Affairs (IVD)... Manager , Regulatory Affairs (IVD) San Diego, CA,...FDA, EU Notified Body , and other international regulatory agencies. This position is focused on in vitro… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …best self. Become a **maker of possible** with us. **Job Overview** The Staff Regulatory Affairs Specialist is part of the team responsible for Core Business ... regulatory subject. + Provides support to Sr. RA manager and RA leadership, supports other RA teams (eg,...+ Requires a minimum of 5 years' experience in regulatory affairs in the device/diagnostic industry. +… more
- Veterans Affairs, Veterans Health Administration (Long Beach, CA)
- …Develops performance standards, assures the program area is compliant with all regulatory and accrediting body requirements, designs and implements orientation ... Care System is recruiting for one (1) SCI Therapy Manager responsible for the professional and administrative management of...standards, assures the program area is compliant with all regulatory and accrediting body requirements, designs and… more
- J&J Family of Companies (Santa Clara, CA)
- … Regulatory Compliance in Shockwave worldwide. Partners with leaders in R&D, Regulatory Affairs , Quality, Legal, Supply Chain, Clinical and Johnson & Johnson ... requirements in the light of current guidance and FDA/International regulatory body field activity. **REQUIRED KNOWLEDGE, SKILLS, ABILITIES,… more
- Hologic (San Diego, CA)
- …leadership of clinical program strategy together with key stakeholder departments (eg R&D, Regulatory Affairs , Marketing, Scientific Affairs ). + Leads and ... + Collaborates with RA/QA in responding to audits and Regulatory Body inquiries. + Acts as an...and objectives + Excellent working knowledge of GCP, clinical affairs , and regulatory affairs The… more
- Abbott (Pleasanton, CA)
- …field + Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/ Affairs experience in medical device manufacturing or other similarly ... their health and get on with their lives. As a Senior Quality Compliance Manager , the individual will play a crucial role within Abbott's Heart Failure organization… more
- Medtronic (Northridge, CA)
- …engineering (mechanical, electrical, firmware, software, manufacturing), operations, marketing, clinical regulatory affairs , quality and other key business ... to lead New Venture programs. In this exciting role as a Program Manager , you will have responsibility for providing program leadership to cross-functional New… more
- AbbVie (Irvine, CA)
- …leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. With our own research ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
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