- Meta (New York, NY)
- …the combination of AI with great form factors can do. We are seeking an experienced medical devices regulatory affairs professional to help us execute ... products with distribution into many worldwide markets. **Required Skills:** Medical Devices Regulatory Affairs...Medical Device Directive & European Union Medical Device Regulation, FDA regulatory … more
- Stryker (Mahwah, NJ)
- …3+ years of experience in an FDA regulated industry + 2+ years of experience in medical device regulatory affairs + Thorough understanding of FDA, ... Europe, and international medical device regulations + Experience drafting regulatory submissions... Affairs ) + Previous experience with Class II/III medical devices + Previous experience drafting 510(k)s… more
- 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 ... **Job Description Summary** Staff Regulatory Affairs Specialist - Franklin Lakes...regulatory authority personnel (eg FDA, Notified Bodies) in medical device and in vitro diagnostic areas.… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … Professional Society (RAPS) certification preferred + 4 years Regulatory Affairs experience in the medical device industry preferred **Knowledge ... Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing...design control documents and product labeling, and evaluate proposed device changes. The Sr. Regulatory Affairs… more
- Stryker (Mahwah, NJ)
- …of managerial/supervisory experience + Understanding of global medical device regulations including direct experience with regulatory submissions associated ... We are currently seeking a **Senior Manager, Regulatory Affairs ** to join our Joint...with US and EU Class II/III medical devices + Ability to lead a… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Associate Director, Regulatory Affairs , Specimen Management (SM) reports directly to the Vice President, Regulatory ... drive success, and leading and inspiring a team of regulatory affairs associates. This role will directly...+ At least 10 years of experience in the IVD/ medical device field with growing responsibility. +… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Advanced degree preferred; medical training preferred. + Minimum 8 years of regulatory affairs experience within the pharmaceutical or medical device ... **Job Description Summary** As Regulatory Affairs Associate Director, you will...strong and respected voice. + Comprehensive knowledge of US medical device regulations (FDA), Clinical Practice standards,… 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...investigation + Minimum of 10 years experience in the Medical Device /In Vitro Diagnostics industry required. More… more
- Wolters Kluwer (New York, NY)
- …portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important ... software launches and market expansions. **Post-Market Surveillance and Regulatory Affairs ** + Coordinate post-market activities including... regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP.… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …compliance, product development, and clinical validation. **Key Responsibilities:** + Strategic Medical Leadership: Drive medical affairs activities ... authorities to support safety, efficiency, and clinical performance claims. + Global Medical Affairs Support: Ensure comprehensive Medical Affairs… more
- Veterans Affairs, Veterans Health Administration (Montrose, NY)
- …various reports; and works in various environmental conditions. Regularly inspects the medical center to identify potential occupational health hazards and the need ... officials concerned with implementation and compliance of statutory and regulatory occupational health requirements. Conducts a full and comprehensive industrial… 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
- Stryker (Mahwah, NJ)
- …Evaluation documentation (eg, CERs, CEPs, SSCPs, PMCFPs, PMCFRs) to bring State of the Art medical devices to market. You will act as the subject matter expert ... an FDA or highly regulated industry required; preferably with medical devices . + A minimum of 2.... + A minimum of 2 years in a Regulatory Affairs role required. + Experience in… more
- Danaher Corporation (New York, NY)
- …adoption strategies + Regulatory Knowledge: In-depth understanding of IVD and medical device regulations with strong familiarity of IVD applications in ... Science Liaison (Sr. MSL) will plan and execute the local and regional Medical Affairs (MA) strategies which are aligned and complement the Global MA strategies.… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …the time **Preferred Qualifications:** + Digital Marketing experience. + Experience in the Medical device industry. + SalesForce experience At BD, we prioritize ... not limited to: revenue growth, profitability, new product development, clinical affairs , regulatory compliance, sales support, pricing strategy, inventory… 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
- ThermoFisher Scientific (Fair Lawn, NJ)
- …matrices. + Collaborate with multi-functional teams such as Quality Assurance, Regulatory Affairs , and Engineering to ensure compliance with industry ... to detail. **Preferred Qualifications:** + Experience in the pharmaceutical, biotechnology, or medical device industry. + Certification in validation or related… 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