- 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
- Bausch Health (Stamford, CT)
- …skills and values drive our collective progress and impact. The Senior Account Specialist (SAS) is an opportunity to support Soltas family of well-known non-invasive ... ethic to include; + Maintaining compliance with all applicable quality and regulatory guidelines including FDA and corporate guidelines. + Supporting company goals,… 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
- 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
- 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
- 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
- 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