- Terumo Neuro (Aliso Viejo, CA)
- …assigned clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical , & Regulatory Affairs Teams, KOLs and physician ... scientific experience. 3. Demonstrated experience in the development of regulatory / clinical submissions (preferably as a medical ...a medical writer for pharmaceutical, CRO, or medical device clients). 4. Excellent writing and… more
- Abbott (Pleasanton, CA)
- …an exciting opportunity for the right candidate to join our Global Clinical and Regulatory Affairs team within the Heart Failure Division (HFD) as the **Director ... failure by collaborating closely with internal stakeholders (R&D, Marketing, Clinical Affairs , Medical Affairs , Reimbursement) and external stakeholders… more
- J&J Family of Companies (Irvine, CA)
- …managers and specialists, collaborating with multiple cross-functional partners including Marketing, Medical Affairs , Clinical Teams, Regulatory Affairs ... training commitment for TRUFILL n-BCA Liquid Embolic System and Enterprise Vascular Reconstruction Device with Clinical Affairs , Regulatory , and Legal teams.… more
- Abbott (Sylmar, CA)
- …solutions comply with relevant regulatory standards and collaborate with Regulatory Affairs to support submission strategies and post-market surveillance. + ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Terumo Neuro (Aliso Viejo, CA)
- …and milestones and to provide regular progress updates. + Support clinical science and regulatory affairs functions by utilizing medical expertise to provide ... committee findings and results. + Partner with clinical research project managers and Medical Affairs and Safety Manager to ensure safety startup activities and… more
- Actalent (San Diego, CA)
- …receipt, and implementation of new and revised labeling. Required Skills: + Experience in medical device labeling and regulatory compliance + Proficiency in ... both new and existing in vitro diagnostic (IVD) and medical device (MD) products. This role requires...Use (IFUs), packaging, and labels. + Collaborate with Marketing, Regulatory Affairs , Supply Chain, Engineering, Clinical, and… more
- Terumo Neuro (Aliso Viejo, CA)
- …Management Professional (PMP) certification is highly desirable. 3. Strong knowledge of medical device development processes, regulatory requirements, and ... Stakeholder Management + Collaborate closely with cross-functional teams, including R&D, regulatory affairs , manufacturing, quality assurance, and marketing, to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Collaborate cross-functionally with Government Affairs , Managed Markets, Value & Access, Medical Affairs , and other internal stakeholders to align on policy ... domestically up to 15%. **Preferred Qualifications** + Experience in the pharmaceutical or medical device industry, or within government agencies such as CMS. +… more
- Abbott (Sylmar, CA)
- …diverse and growing portfolio of digital health products, including software as a medical device (SaMD), connected devices, and digital health platforms. This ... continuous improvement **Qualifications** + Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs , or related field (Master's or RAC certification… more
- Terumo Neuro (Aliso Viejo, CA)
- …requirements and international standards along with cross-functional input from Marketing, R&D, Regulatory Affairs , and Legal. Job duties: + Responsible for ... that meet the needs of customers and all regional regulatory requirements. + Plan and execute label development schedule,...(5) years of relevant experience in product labeling in medical device field. 3. Minimum one (1)… more
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