- Meta (New York, NY)
- …a scientific discipline or equivalent work experience 6. 6+ 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
- Pentax Medical (Montvale, NJ)
- … and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical ... future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist : + Coordinate with...regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices … more
- IQVIA (New York, NY)
- …data, etc.), HCP engagement by life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would also ... **Manager, Medical Affairs Strategy** **Overview** IQVIA is...diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies as well… more
- Capgemini (New York, NY)
- …and lessons learned. **Skills & Experience (Required)** + **12 years** in regulatory affairs ; direct leadership of **IND/NDA/BLA/MAA** submissions (10 successful ... **Title:** _Capgemini Invent - Senior / Managing Consultant - Life Sciences, Regulatory Affairs & Quality_ **Location:** _NY-New York_ **Requisition ID:**… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … role within the core team, aiding product development, remediation projects, and meeting medical device regulatory needs. + Review, comprehend, and compose ... devices to align with global regulations. + Support regulatory submissions towards EU MDR requirements, including but not... device or pharmaceutical industry (clinical research or medical affairs ) + Experience in medical… more
- Veterans Affairs, Veterans Health Administration (East Orange, NJ)
- …or radiological devices involving their interfaces and connections to other medical devices or information systems either directly or through the facility's ... hardwired and wireless networks. Adheres to Medical Device Isolation Architecture Guidelines in both...assigned, employee is responsible for lifecycle management of other medical devices and systems such as life… 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)
- …Bioengineering, Biology, Chemistry). + Minimum of 5 years of Regulatory Affairs experience in medical devices , preferably sterile single-use disposable ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist will represent...Q-Sub), EU technical documentation under MDR, and other global regulatory filings. + Evaluate medical device… more
- Danaher Corporation (New York, NY)
- …company product teams to execute with supporting organizations (sales, commercial marketing, medical affairs , R&D, manufacturing, regulatory , quality, etc.) ... Finance, R&D, Regulatory Affairs , Clinical Affairs , Sales & Marketing, Corporate Development, Medical ...corporate, global or regional marketing role involving diagnostic or medical device products/services. + Exposure to P&L… more
- Mount Sinai Health System (New York, NY)
- …studies + 3+ years of direct experience in Regulatory Affairs , Clinical Affairs or Quality Assurance within the Medical Device Industry Preferred: + ... **Job Description** A Regulatory Compliance Coordinator position is currently available within...medical knowledge preferred. **Responsibilities** + Protocol development: Provides regulatory support to clinical trial project teams. Work with… more