- 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
- Danaher Corporation (New York, NY)
- …core labs, Define product vision, roadmap, and key requirements in collaboration with R&D, regulatory , medical affairs , and commercial teams + Build and ... 9+ years relevant experience + Product Management experience in diagnostics, biotechnology, medical devices or related fields with hands-on leadership in… 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
- Organon & Co. (Jersey City, NJ)
- …Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, as well as ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , ... in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is… 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. (Bronx, 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is ... respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several… more