- Chemours (Albany, NY)
- …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
- Meta (New York, NY)
- …**Minimum Qualifications:** Minimum Qualifications: 8. 7+ years of industry experience in medical device regulatory affairs or related industry 9. ... commercialized in the smart wearables and software as a medical device direct to consumer space. You... landscapes and driving successful product registrations. **Required Skills:** Medical Devices , Regulatory Affairs Lead… 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 ... a 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
- LSI Solutions (Victor, NY)
- …to gather regulatory intelligence regarding updates to US and international medical device regulations, and supporting Rest-of-World (ROW) regulatory ... govern the design, development, manufacturing, and distribution of our medical devices . REPORTS TO: REGULATORY ... medical records. + A rudimentary understanding of Regulatory principles that govern medical device… more
- Danaher Corporation (New York, NY)
- …and market access. The essential requirements of the job include: + 5+ years of regulatory experience in IVD medical devices , with a Bachelor's, Master's, or ... cross-functional design and development team to support both IVD medical device and Research Use Only (RUO)...regulations. + Knowledge of CE Marking processes, including for non- medical devices . Leica Biosystems, a Danaher operating… more
- Canon USA & Affiliates (Albany, NY)
- …Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum ... ** Regulatory Affairs Specialist - Post Market - req1434**...$72,000 to max $116,100 (annual equivalency) **_About us!_** _Canon Medical Systems USA, Inc., a world leader in diagnostic… 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 ... 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external... regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP.… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …development lifecycle of an off the shelf, or an internally designed platform medical device delivery system. + Defines detailed product requirements and ... equivalent combination of education and experience Previous experience in combination product/ medical device development or similar area is required. Experience… more
- TD Bank (New York, NY)
- …economic information, and key industry developments, as well as internal policies and regulatory standards (as communicated by Compliance) at all times to assist in ... lines, corporate, and/or control functions and ensures alignment with enterprise and/or regulatory requirements + Maintains a culture of risk management and control,… more
- WMCHealth (Warwick, NY)
- …within the facility to maintain accurate and orderly records meeting the regulatory requirements. Responsibilities: Medical Records + Manage Medical ... release of record, conferring with legal departments. + Oversees the release of Medical Records to other providers, regulatory agencies, billing agencies, and… more
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