- Meta (New York, NY)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …required (eg, engineering, bioengineering, biology, chemistry). + Minimum 5 years Regulatory Affairs experience in medical device or in vitro diagnostic ... has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing...regulatory authority personnel (eg FDA, Notified Bodies) in medical device and in vitro diagnostic areas.… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …field. Advanced degree preferred. + Minimum of 5 years Regulatory Affairs experience in medical devices , preferably sterile single-use disposable ... **Job Description Summary** The Staff RA Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform on… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …decisions and guide product strategy -- May include cross-functional collaboration with R&D, Medical Affairs , Market Access, Regulatory Affairs and ... (eg, presentations/publications focused on surgical device modeling, ISPOR Surgery or Medical Device SIG). + Has substantial hands-on experience planning and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …a **maker of possible** with us. Reporting directly to the business unit Vice President of Medical Affairs , the Director of Medical Affairs has the ... responsibility to support the VP, Medical Affairs in providing medical , scientific and technical...NJ** + Minimum of 10 years' experience in the Medical Device /In Vitro Diagnostics or related industry… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …creation, and integration with design control processes. + Collaborate cross-functionally with R&D, Regulatory Affairs , Medical Affairs and Marketing ... ongoing maintenance and improvement of product risk files for medical devices . This role is responsible for...relevant experience **Skills:** + Extensive knowledge of the FDA medical device quality system regulations and international… more
- Grifols Shared Services North America, Inc (Manhattan, NY)
- …regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides ... staff + May have responsibility for maintaining a compliant medical device quality system for R&D and...years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …+ Ensure program success by working cross functionally with R&D-Engineering, Marketing, Medical Affairs , Manufacturing, Quality and Regulatory Affairs ... knowledge of material science and engineering principles + Working experience in medical device industry + Familiar with design control process and medical … more
- Danaher Corporation (New York, NY)
- … regulatory , market access, and post-market). You'll collaborate with clinical, regulatory /quality, R&D, medical affairs , IT/security, and our Operating ... and visualization tools. + Proven experience analyzing RWE/RWD (EHR, claims, registries, device logs) for clinical, regulatory , or market access impact. Travel,… more
- Philips (Stamford, CT)
- …of experience in Medical /Clinical Affairs or equivalent in the medical device industry. Strong knowledge and experience working in the cardiovascular ... trends, and supports stakeholder awareness. + Ensures compliance with medical affairs activities, including Investigator Initiated Research...domain and with cardiovascular medical device products is required. Experience with… more
- Cordis (New York, NY)
- …key clinical and scientific insights to internal stakeholders-such as Clinical Development, Medical Affairs , and Commercial teams, helping shape strategy and ... and medical information between KOLs, other investigators and the company's Medical Affairs , Marketing and R&D groups. + Propose strategic solutions to… more
- Edwards Lifesciences (New York, NY)
- …surgery or interventional cardiology are strongly preferred; candidates with other relevant medical device clinical sales support experience will be considered + ... Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. After extensive… more
- Otsuka America Pharmaceutical Inc. (New York, NY)
- …coordinating with other local Neuroscience Specialists and cross functional colleagues in Medical Affairs (MSLs) and Market Access (RAMs) under appropriate ... **Position Overview** This position requires a deep understanding of regulatory requirements, operational challenges, and the distinct clinical and...+ A minimum of 2 years of pharmaceutical or medical device sales experience. + Must reside… more
- System One (Park Ridge, NJ)
- …directly impact product safety, regulatory success, and speed-to-market for critical medical devices and healthcare products. As a recognized authority, you ... + Partner with product development, packaging, operations, quality, and regulatory affairs to integrate microbiological and sterilization requirements… more
- WMCHealth (Valhalla, NY)
- …reimbursement requests at the conclusion of patient's participation in protocol + Regulatory Affairs : Responsible for preparing and submitting new research ... and as the operational liaison for other research organizations, funding agencies and regulatory bodies. + Assists in training PIs and other research staff on the… more
- Danaher Corporation (New York, NY)
- …Managers towards it; build and maintain strong relationships with R&D, Clinical & Regulatory Affairs , Marketing, Operations, and Quality + Own & improve Beckman ... lifecycle management within the Diagnostics industry or a related field (eg, Medical Device , Pharmaceuticals, Biotechnology, Life Sciences) and a deep knowledge… more
- Dow Jones (New York, NY)
- …and the businesses that run it, from the pharmaceutical makers and biotech, to medical devices , hospitals and pharmacy benefit managers.** This is a critical ... is now under assault from threatened tariffs, funding cuts and a shifting regulatory environment. And they own vast oceans of highly personal data that, combined… more