- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... Experience** + 3-5 years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience + Experience with US FDA regulations (Title… more
- Bausch Health (Bothell, WA)
- …Bachelors Degree Required Life science or technical discipline preferred. Minimum 6 years regulatory experiences in MNC medical device company (aesthetic ... device is a plus). Demonstrates profound knowledge and expertise in Active Medical Device international regulations, focus on US/Canada/MDR and APAC is a… more
- Bausch Health (Bothell, WA)
- … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… 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
- System One (Malvern, PA)
- …or equivalent, in life sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. ... Job Title: Director of Regulatory and Medical Affairs Location: Malvern,...Manage and maintain ongoing submissions such as annual reports, medical device facility registrations and device… 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
- Chemours (Boston, MA)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- US Tech Solutions (San Bruno, CA)
- …of Quality Concepts (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, Notified ... + Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring...and mentoring to engineers to ensure audit readiness and regulatory submissions. + Support bringing novel medical … more
- Meta (New York, NY)
- …scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. Experience ... **Summary:** We're seeking a regulatory affairs specialist to join our medical...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
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