- GRAIL (Washington, DC)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals is required.… more
- FleishmanHillard (Washington, DC)
- …intersection of healthcare and public affairs in service to pharmaceutical and medical device companies, as well as third party organizations to include ... Additional desired areas of expertise include issues advocacy and public affairs campaigns, strong writing skills, and stakeholder engagement with policy and… more
- Oracle (Washington, DC)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Cardinal Health (Washington, DC)
- …in related field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**... and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory … more
- Gilead Sciences, Inc. (Washington, DC)
- …directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16 years ... and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory ...or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Fujifilm (Washington, DC)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Sanofi Group (Washington, DC)
- …strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team...teams. + Contribute to and execute innovative and sustainable medical device regulatory strategies covering… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Philips (Washington, DC)
- …a minimum of 10+ years' experience in FDA Regulations, Global Regulatory Affairs , Policies and Standards within the Medical Device /Technology industry or ... The Regulatory Science & Policy Director is responsible for...Director is responsible for guiding the analysis of global regulatory requirements, policies and industry standards to identify their… more
- Edwards Lifesciences (Washington, DC)
- …Bachelor's Degree in a related field with 5 years of related experience working in medical affairs , clinical affairs and/or clinical science **What else we ... internal/external working relationships + The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment… more
- Fujifilm (Washington, DC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... support clinical studies, evidence generation, and publication strategies. + Support Regulatory Affairs with product documentation, claims substantiation, and… more
- Guidehouse (Mclean, VA)
- …FDA/ICH guidelines and CDISC data standards + Experience in pharmaceutical industry regulatory affairs and/or quality assurance and/or quality control + Direct ... market research and technical evaluation panels. You'll also advise on clinical, regulatory , and manufacturing aspects of medical product development, ensuring… more
- Philips (Washington, DC)
- ** Medical Education Program Specialist** You will be responsible for the development, facilitation, execution, documentation, and monitoring of our customer-facing ... Structural Heart Disease (SHD) medical training and educational programs as part of a...forecasting, while maintaining vendor relationships and financial compliance. Uphold regulatory standards and audit readiness for all educational activities,… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device ), with 3-5 years in in pharmaceutical quality, with specific ... or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs . **Competencies** **Accountability for Results -** Stay focused… more
- Edwards Lifesciences (Annapolis, MD)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
- BD (Becton, Dickinson and Company) (Hunt Valley, MD)
- …independently writing and executing process validation protocols. + Experience in a medical device or pharmaceutical manufacturing facility. + Moderate knowledge ... of possible** BD is one of the largest global medical technology companies in the world. Advancing the world...degree. + Typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs . + Other fields can be… more
- BD (Becton, Dickinson and Company) (Hunt Valley, MD)
- …functional groups: Manufacturing, Procurement, Supply Chain, Marketing, Quality Management, Regulatory Affairs , R&D, and Distribution. This position also ... field + 1-5 years Package Engineering experience. Background in the healthcare, medical device manufacturing industry, and/or an FDA-regulated industry a plus… more
