- Meta (New York, NY)
- **Summary:** We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as ... wearables, and other innovative devices . **Required Skills:** Medical Devices , Regulatory Specialist...work experience 6. 3+ years of industry experience in medical device regulatory affairs or… more
- Meta (New York, NY)
- …with distribution into many worldwide markets. **Required Skills:** Medical Devices Regulatory Affairs Strategy Specialist Responsibilities: 1. Act ... form factors can do. We are seeking an experienced medical devices regulatory affairs professional...Medical Device Directive & European Union Medical Device Regulation, FDA regulatory … more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …US, EU, and other global regulatory requirements are met. + Evaluates medical device regulations and leads development of global regulatory strategies ... and evaluate proposed device changes. The Sr. Regulatory Affairs Specialist is able to interpret...4 years Regulatory Affairs experience in the medical device industry preferred **Knowledge & Skills:**… more
- Stryker (Mahwah, NJ)
- …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...Regulatory Affairs) + Previous experience with Class II/III medical devices + Previous experience drafting 510(k)s… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Artwork Senior Specialist is responsible for the regulatory role as part of the process for coordination, development, ... development, tracking and completion. + Support global labeling process for device development including metrics tracking. + Support IT initiatives including… more
- Edwards Lifesciences (Newark, NJ)
- …+ Knowledge and understanding of cardiovascular science + Moderate understanding of medical device regulatory requirements and documents, device ... (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) or related medical device , clinical, or Certification in RDCS (Registered Diagnostic… 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 ... you will do** + Prepares clinical documentation to validate device safety and performance for regulatory body...an FDA or highly regulated industry required; preferably with medical devices . + A minimum of 2… more
- Edwards Lifesciences (New York, NY)
- …**_Note: this Clinical Specialist will support field cases for EVOQUE (tricuspid device ) in the local region, along coverage when needed in the broader US_** ... the world. As a part of the Field Clinical Specialist team, you will be a critical part of...you will make an impact:** + Educate physicians on device handling, implantation and troubleshooting techniques related to the… more
- Rep-Lite (Manhattan, NY)
- …to implantable or neuromodulation devices + Previous experience supporting medical device or pharmaceutical products + Ability to communicate effectively ... Associate Clinical Specialist - Neuromodulation Full-Time | Field-Based | Travel...This role is ideal for individuals early in their medical device career who want to grow… more
- Edwards Lifesciences (Newark, NJ)
- …surgery or interventional cardiology are strongly preferred; candidates with other relevant medical device clinical sales support experience will be considered + ... the world. As a part of the Field Clinical Specialist team, you will be a critical part of...cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force… more
- Stryker (Mahwah, NJ)
- … agencies **Preferred** + Thorough knowledge and understanding of US and International Medical Device Regulations. + Strong knowledge of Quality Systems (CAPA, ... Stryker is seeking a **Senior Quality Systems Specialist ** for our Joint Replacement division. This is a hybrid position based in Mahwah, NJ or Weston, FL. As the… more
- Honeywell (Morris Plains, NJ)
- …food, drug and device regulation and product safety. The Product Stewardship Specialist is a key team member of the regional Product Stewardship Americas team, ... superior value to our customers every day. The **Product Stewardship Specialist ** provides expert product stewardship guidance and leadership to businesses and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …relevant experience. **Knowledge and Skills:** + Working knowledge of the FDA medical device quality system regulations and international quality system ... **Job Description Summary** The Staff Quality System Specialist I is accountable for support of the...of possible** BD is one of the largest global medical technology companies in the world. Advancing the world… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …experience. **Knowledge and Key Skills:** + Working knowledge of the FDA medical device quality system regulations and international quality system ... **Job Description Summary** The Sr. Quality System Specialist is accountable for support of the continued...of possible** BD is one of the largest global medical technology companies in the world. Advancing the world… more
- Amazon (New York, NY)
- Description AWS is seeking a Security Assurance Specialist who will drive the strategy that enables every customer, in every sector of the United States. This ... You will have a desire to learn and understand the complexities of legal, regulatory and compliance requirements across all sectors of your region. You will be… more
- Antech Diagnostics (New York, NY)
- …and Multi-Factor Authentication (MFA), self-service password reset solutions, device -based authentication, identity protection, among others. + Manage and ... Experience in regulated industries (finance, healthcare, manufacturing, etc.) applying regulatory regulations and/or security frameworks. + Experience in a… more
- Atlantic Health System (Morristown, NJ)
- …be supporting all of our radiology equipment in our Northern New Jersey Medical facilities. + Working knowledge of general X-ray equipment and specific training in ... as a front-line responder for escalated service events. Possesses understanding of medical PCs, peripherals, medical network hardware and clinical network… more
- Antech Diagnostics (New York, NY)
- …accordance with industry accepted standards for veterinary and health devices security including encryption, disaster recovery, authentication, audit logging, ... Experience in regulated industries (finance, healthcare, manufacturing, etc.) applying regulatory regulations and/or security frameworks under a quality management… more