- Fresenius Medical Center (Ogden, UT)
- …regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc.) + Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ... + Support Product Center/Project Manager to get part needed to Medical Device Compliance and Regulatory Affairs to complete Technical Dossier/Registration dossier. +… more
- ConvaTec (Boston, MA)
- …global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ... range of benefits, from infection prevention and protection of at- risk skin, to improved patient outcomes and reduced care...medical products,** and will serve as project lead or specialist . They will interface with Marketing, Clinical, and users… more
- Integra LifeSciences (Princeton, NJ)
- …knowledge who provides support to multifunctional teams (ie, ClinOps, Regulatory, Quality, Risk Management , Complaints, and Medical Affairs). MSS provides ... and making headway to help improve outcomes. Medical Safety Specialist (MSS) is a medical professional with clinical experience...risk management and safety input to NPI/sustaining Quality Assurance teams… more
- ConvaTec (Lexington, MA)
- …short of excellence. Join us on our journey to #ForeverCaring as a Clinical Study Management Specialist , and you'll do the same. **About the Role** The Clinical ... Study Management Specialist provides operational expertise to ensure...to detail. + Excellent collaborative team player. + Medical Device experience essential. + Previous line management … more
- AdventHealth (Altamonte Springs, FL)
- …we are even better. **Schedule:** Full Time **The role you'll contribute:** **The Third Party Risk Management (TPRM) Specialist - Senior,** as part of the ... . Contribute in the enhancement and delivery of a comprehensive Third Party Risk Management program through the continual review, evaluation, and testing of… more
- Abbott (Plymouth, MN)
- …international medical device regulations and submissions. + Experience with risk management , design verification, or process validation work. + Proficient ... **The Opportunity** Abbott is seeking a passionate, experienced **Senior Regulatory Affairs Specialist ** to join our team on-site in Plymouth, or St. Paul, MN.… more
- Burrell Behavioral Health (Springfield, MO)
- Job Description: Job Title: IT Asset Management Specialist Location: Springfield, Missouri Department: Information Technology Employment Type: Full-time Shift: ... and other valuable resources? Deliver precision and optimization as an IT Asset Management Specialist with our team in Springfield, Missouri! As an integral… more
- Medtronic (Northridge, CA)
- …GCP and current regulations for those undertaking clinical studies + Support risk management operations, including ongoing review of literature and compilation ... **Careers that Change Lives** We are excited to be hiring a **Sr Clinical Quality Specialist ** to join the Medtronic Diabetes Operating Unit. In this role, you will… more
- Hologic (San Diego, CA)
- Regulatory Affairs Specialist 3 San Diego, CA, United States Hologic is seeking a Regulatory Affairs Specialist responsible for leading Hologic Diagnostics ... and external resources regarding clinical performance and assessment of diagnostics products benefit/ risk and "State of the Art" as required to meet European IVDR… more
- Jacobs (Tampa, FL)
- …Performs assessment and authorization coordination. Advises and assists the customer with Risk Management Framework (RMF) and develops a Plan of Action ... of information security, vulnerabilities, security controls, and threats to support organizational risk management decisions. . + Identify, assess, and advise on… more
- ThermoFisher Scientific (Cambridge, MA)
- …is safe, and helping find cures for cancer. The **Senior Compliance Specialist ** is responsible for ensuring the Organization's compliance profile meets global ... opportunities across all of its sites and operations for management to ensure that appropriate and timely action can...timely action can be taken to reduce the overall risk to the company. The program accomplishes this through… more
- Abbott (Alameda, CA)
- …**The Opportunity** Responsible for timely review, documentation and filing of Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, ... Medical Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest of world for the division's products. Interact with… more
- Abbott (Orlando, FL)
- …and Information Security in providing internal control assessment, auditing and monitoring, risk management and mitigation. This role will work to identify ... mothers, female executives, and scientists. **THE OPPORTUNITY** This **Cybersecurity Specialist ** position can work out in one of the...regulations to include US HIPAA and EU GDPR + Risk Management experience + Development process and… more
- Dominion Energy (Richmond, VA)
- …Generation Engineering and corporate policies, and procedures. * Support the strategic management of network device information and configurations for Power ... Generation Network Specialist - Generation Operational and Communication Technology (Richmond,...its auxiliaries: * Support SCADA and ICS managed network device configurations (eg network switches, routers, firewalls) and architectures… more
- Kelly Services (Cuyahoga Falls, OH)
- Kelly Science & Clinical is seeking a **Senior Regulatory Affairs Specialist near Cuyahoga Falls, OH.** **Direct Hire** **Shift:** Monday - Friday 8am-5pm Hybrid: 2 ... and maintaining regulatory functions and systems to ensure continuous medical device and environmental regulatory compliance. + Assist in maintaining the Quality… more
- Veterans Affairs, Veterans Health Administration (Tuskegee, AL)
- Summary This is a Supervisory Biomedical Equipment Support Specialist (BESS) position located at the Central Alabama Veterans Healthcare System (CAVHCS) in the ... Engineering service. Responsibilities The Supervisory Biomedical Equipment Support Specialist (BESS) provides clinical and administrative support to staff, patients,… more
- Integra LifeSciences (GA)
- …rework of non-conforming product CAPA, SCAR, HHE and Field Actions. Support product risk management in accordance with FDA/ISO 14971. + Work independently or ... and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible for contributing to and… more
- Dominion Energy (Richmond, VA)
- …Generation Engineering and corporate policies, and procedures. + Support the strategic management of network device information and configurations for Power ... Network Specialist - Power Generation Controls and Operational Technology...fleet and its auxiliaries: + Support ICS managed network device configurations (eg network switches, firewalls, routers) and architectures… more
- ThermoFisher Scientific (West Hills, CA)
- …HLA Typing kits and reagents. Validation work includes the ability to perform risk assessments to identify the extent of validation required. The QA Specialist ... for validation and new design processes. The application of risk assessment methodology is required for this position in...methods, and documentation to support the DMR. The QA Specialist II may sit on Core Teams or assist… more
- Philips (Orange, OH)
- **Principal Regulatory Affairs Specialist (US Hub based)** Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. ... Our Capsule Surveillance product is a clinical decision support software medical device (SaMD) that uses patented "smart rules" to deliver actionable alerts to… more