- Meta (Seattle, WA)
- …a medical device (SaMD). **Required Skills:** Head of Medical Devices Regulatory Affairs Responsibilities: 1. Lead project teams for end-to-end ... **Summary:** Reality Labs is seeking an experienced medical devices regulatory affairs...product approvals for novel hardware and software as a medical device products for distribution into many… more
- System One (Billerica, MA)
- …ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282) + Experience in leading and/or supporting medical device regulatory inspections by FDA and Health Canada, ... Title: Head of QA Medical Device...Title: Head of QA Medical Device Location: Billerica, MA (can...standard operating procedures (SOPs) related to medical devices and associated systems aligning with regulatory … more
- Gilead Sciences, Inc. (Foster City, CA)
- …of clinical studies, audit and inspection readiness/support, training, ICSR excellence, and Medical Device / Combination Product safety. Gilead Sciences is ... individual to join the **PS Strategic Operations** team as a **Director, PS Medical Device Safety** responsible for developing and leading implementation of… more
- CSL Behring (King Of Prussia, PA)
- …R&D GxP spectrum - GLP, GCP, GCLP, GVP and GMP as well as medical device and combination products regulations. Quality oversight is provided for toxicology ... studies, clinical development, clinical supply manufacture and packaging and medical device development. Quality oversight and management systems for… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …role is at the forefront of developing and implementing Software as a Medical Device (SaMD) strategies, overseeing product platforms, and ensuring compliance ... with regulatory protocols. The Head of Digital Health...US based employees may be eligible to participate in medical , dental, vision insurance, a 401(k) plan and company… more
- Organon & Co. (Plymouth Meeting, PA)
- …in biological science, chemistry or related discipline preferred. + 12-15 years of drug/ medical device development experience, the majority of which was in US ... promotional regulatory strategy in collaboration with Commercial, PRT, Global Regulatory Liaisons, Medical Affairs and Worldwide Product Labeling. + Guide… more
- Amgen (Washington, DC)
- …pharmaceuticals, natural science or medicine + Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling + Experience in ... proud of. **Global Labeling Strategy Sr. Manager - TA Head ** **Live** **What you will do** Let's do this....Organizational expert within defined subject area + Experience in Medical Device industry, including Design Controls and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …microbiological liaison, data analytics, epidemiological investigative principles, medical device /technology product evaluation, performance improvement, ... prevention experience with patient safety, including hospitals, academia, health systems, medical device and/or pharmaceutical manufacturers. + Domestic and… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview The Head , GCP Quality Assurance provides strategic leadership and direction for clinical ... other prioritized needs, ensuring Rhythm's drug development programs comply with regulatory standards and driving continuous improvement of Good Clinical Practices… more
- Olympus Corporation of the Americas (Westborough, MA)
- …adhering to regulatory and legal requirements needs to be ensured. The Global Head of Medical Data Office drives the development and continuous adoption of ... Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill… more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head , GRS, is responsible for the ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...management of global regulatory leads with product and disease state expertise for… more
- Philips (Bothell, WA)
- …if:** + You've acquired a minimum of 10 years' experience working in FDA regulated medical device quality, with a focus in Design Quality Engineering in support ... As a key member of the Philips Ultrasound Quality Organization, the Head of Design Quality Engineering will lead and develop a global team of Design Quality… more
- Curia (Albuquerque, NM)
- …responsibilities in Quality Operations in the pharmaceutical (sterile product manufacture)/Biologics/ medical devices industry, including project, technical, and ... The Site Head of Quality is also responsible for directing...to achieve a consistent approach to Quality Assurance and Regulatory Affairs. + Direct quality and compliance process improvements… more
- Truist (Charlotte, NC)
- …(United States of America) **Please review the following job description:** The Head of Cloud Architecture will lead the bank's enterprise-wide cloud strategy, ... cloud adoption approach that aligns with business objectives, ensures regulatory compliance, leverages best-of-class technologies, and maintains high standards of… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …exceptional benefits package to employees and their families which include comprehensive medical , dental, and vision coverage with no premiums, generous paid time ... essential to addressing the TB epidemic. Your Role The Head of HIV Drugs is a new position within...formulation and drug product; clinical trials; GMP manufacturing; and regulatory submission and approval requirements. + Experience in developing… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Serves as a principal assistant to the Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs. Responsible for management of the delivery ... by the Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs, including...formulary and other patient access activities, clinical trials, continuing medical education activities, medical device … more
- Philips (Cambridge, MA)
- …fit if:** + You have a minimum of 7 years' experience in FDA Regulated Medical Device /HealthTech environments, with a focus on the preparation and submission of ... Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant...in Design Controls. + You have detailed knowledge of medical device regulations (21CFR), FDA law, MDD/MDR,… more
- Englewood Lab, Inc (Totowa, NJ)
- …, inspecting, auditing or manufacturing experience - a plus. + Experience of drug, cosmetic, medical device regulatory process is a pre-requisite Benefits + ... of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. + With the assistance of Head...industry or related experience in any combination of cosmetic, medical device , food, or pharma is required.… more
- Englewood Lab, Inc (Totowa, NJ)
- …degree (Life Sciences, Engineering, related profession). + Experience of drug, cosmetic, or medical device regulatory is a pre-requisite. + Familiarity with ... regulatory agencies under the direct supervision of the Head of Quality. + Assist the Manager during periodic...industry or related experience in any combination of cosmetic, medical device , food, or pharma is required.… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …related field within the healthcare industry and experience in SaMD( Software as a Medical Device ). + Proven track record in developing and managing ... to the best of my knowledge. **Job Description** **R0128042 Regulatory Protocol Framework Lead** **Takeda Pharmaceutical** **USA - MA...Patient Digital Solutions team , you will report to Head of Patient Digital Solutions & SaMD Service Line-Data,… more