- Cytiva (Pensacola, FL)
- …Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device , Biopharma, or other FDA or EPA-regulated ... Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.Quality Management… more
- Beckman Coulter Diagnostics (Miami, FL)
- …regulations and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European Union ... Medical Device Directives (MDD), and In-Vitro Medical ...Regulation (IVDR) as well as all other applicable global regulatory requirements.Maintain oversight, tracking, metric reporting and escalation of… more
- Cytiva (Miami, FL)
- …project engineering role, preferably in healthcare manufacturing or medical device production.2+ years experience with regulatory standards and quality ... into clear, concise language for a non-technical audience.Working in Pharmaceuticals or Medical Device industryExperience with Veeva & Magic systemsCytiva, a… more
- Integrated DNA Technologies (IDT) (Miami, FL)
- …of experience in a regulated environment or GMP compliant environment (Pharmaceutical, Medical Device , OTC Drug, Cosmetic, etc.)Experience with basic statistical ... support of the stability program, including review and implementation of regulatory requirements for the stability program.Coordinate with Quality Control management… more
- Cytiva (Miami, FL)
- …in Quality or Regulatory in a regulated industry (ISO 9001, medical device , or pharmaceutical preferred).Experience with root cause analysis, CAPA ... providing quality leadership in manufacturing and design, ensuring compliance with regulatory standards and driving process improvements; leading root cause analysis… more
- Cytiva (Duncan, SC)
- …contamination control and sterility assurance within the pharmaceutical, biotechnology, or medical device industries.In-depth knowledge of regulatory ... related to contamination controls and sterility assurance.Ensure compliance with regulatory requirements and industry standards for sterility and contamination… more
- Cytiva (Miami, FL)
- …walks.It would be a plus if you also possess previous experience in: Medical Device , eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949#LI-OnsiteJoin our ... (QE Complaints and Deviations).Ensure supplier compliance to QMS and regulatory requirements through supplier monitoring process.Who you are:Bachelor's degree in… more
- Cytiva (Miami, FL)
- …walks.It would be a plus if you also possess previous experience in: Medical Device , eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949Speaking fluent ... (QE Complaints and Deviations).Ensure supplier compliance to QMS and regulatory requirements through supplier monitoring process.Who you are:Bachelor's degree in… more
- LCI-Lawinger Consulting (Minneapolis, MN)
- …team, you will play a critical role in ensuring the safety, effectiveness, and regulatory compliance of medical device products. Key Responsibilities: + Lead ... Engineering, or related field (or equivalent experience). + 5+ years of experience in medical device design assurance, with a deep understanding of FDA and ISO… more
- System One (Pasadena, CA)
- …teams or distributors + Industry Knowledge: Strong understanding of the healthcare industry, regulatory requirements, and medical device products. + CRM & ... Job Title: Regional Sales Manager ( Medical Device ) Location/Remote: Los Angeles, CA Reports to: VP - Ortho Biologics Salary: $100,000 + Generous Commission Fast… more
- Takeda Pharmaceuticals (Boston, MA)
- …progress/results to leadership teams + Monitor and interpret relevant global and local medical device regulatory developments, assessing their impact on ... Medical Safety, LOCs, Global Clinical Development, Global Regulatory Affairs, Device Quality, PV Compliance etc....and external stakeholders, including the Medical Safety, Device Quality Assurance, and Regulatory Affairs, Notified… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... with 10 years regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory experience required. + At least 10… more
- Caldera Medical (Westlake Village, CA)
- …your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR,… more
- Fujifilm (Columbus, OH)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... **Position Overview** This position is intended to sell Fujifilm medical imaging devices, options, and service contracts to prospective and existing customers in… more
- Fujifilm (Durham, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... skills + Knowledge of web software, network and IT, medical devices, regulated environments + Working knowledge of DICOM,...against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- Actalent (Agoura Hills, CA)
- Description As a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ MS preferred, BS or comparable required + Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven ... and guidelines related to Artificial Intelligence, Software as a medical device and Machine Learning. + Assess...in Regulatory Affairs for Software as a Medical Device and Class I/II/III medical… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Job Responsibilities** The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion ... years of experience in Regulatory Affairs working with complex medical device systems and software strongly preferred. * Experience working with external… more
- Actalent (Davis, CA)
- … Affairs Specialist Looking for a candidate that has at least 2-5 years of regulatory experience within Medical Device Class II. MUST HAVE: Regulatory ... experience in Regulatory Affairs and Quality Assurance within the diagnostic or medical device industry. + In-depth knowledge of FDA regulations (21 CFR) and… more
- Eurofins (Boston, MA)
- …strategic vision and team to support our clients in the medical device industry across their product innovation, regulatory compliance, and quality assurance ... + Build and lead a team of skilled consultants with expertise in medical device testing, regulatory affairs, and quality management. + Foster a culture… more
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