- Baylor Scott & White Health (Frisco, TX)
- …hours, nightsEmployment Type: Staff Location/Facility Baylor Scott & White Medical Center - Centennial (Frisco) Specialty/Department/Practice Labor & Delivery Rooms ... sterile supplies and equipment to surgeons and assistants during procedures, holds retractor devices , and acts to anticipate and respond to the surgical team's needs… more
- Sutter Health (San Mateo, CA)
- …you are interested in joining Sutter Health!Organization:MPHS-Mills-Peninsula Medical CenterPosition Overview:Competently performs routine and specialized nuclear ... and supplies periodically to maintain established stock levels.SAFETYImplements protection devices and safety standards to minimize radiation exposure (as low… more
- Baylor Scott & White Health (Plano, TX)
- …Staff Title: Ultrasound Technologist Employee Status: Part-Time Location: Baylor Regional Medical Center - Plano BENEFITS Our competitive benefits package empowers ... patient and area for procedure by positioning patient, adjusting immobilization devices , moving equipment into specified position and adjusting equipment controls to… more
- Baylor Scott & White Health (Grapevine, TX)
- …patient and area for procedure by positioning patient, adjusting immobilization devices , moving equipment into specified position and adjusting equipment controls to ... shielding precautions taken, consent forms, policies and procedures, etc Maintains medical imaging records in appropriate system and according to department policies… more
- AbbVie (North Chicago, IL)
- …objectives, both strategic and applicable regulatory requirements. Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible for the ... management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA)...quality oversight of GxP activities, covering the AbbVie drug, device and cosmetic portfolio. The role oversees generation and… more
- Amazon (Sunnyvale, CA)
- …tablets, Fire TV and Echo Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be ... Sciences, Biology (or equivalent qualifications) - . Experienced in regulatory submissions for Medical Devices ,...verbal, presentation, and organizational skills. - . Experience with medical device software requirements. - . Ability… more
- AbbVie (Irvine, CA)
- …field, plus 4 years' experience in regulatory affairs. + Experience in US medical devices regulatory affairs is necessary. + Demonstrated experience of ... team to resolve complex project issues. + Utilize US device regulatory expertise and extensive knowledge of... regulatory submissions. + Advanced knowledge of US medical device regulations. + Ability to function… more
- AbbVie (Irvine, CA)
- …field, plus 2 years' experience in regulatory affairs. + Experience in US medical devices regulatory affairs is necessary. + Demonstrated experience of ... in support of regulatory submissions. + In-depth knowledge of US medical device regulations. + Ability to function in a controlled environment regulated by… more
- J&J Family of Companies (Warsaw, IN)
- Regulatory Affairs Specialist II (DePuy Synthes) - Medical Device Business Services, Inc.) - 2406189873W **Description** **DePuy Synthes, Inc** ., part of ... of relevant regulatory experience is **required** ; Medical Device experience _highly desired_ . *... device regulations and Class II and III medical devices submissions is preferred. International … more
- Actalent (Carlsbad, CA)
- …and manages necessary regulatory and project management activities required for medical device registration and compliance, with a focus on European ... global regulatory dossiers with a focus on Medical Device Technical Files in accordance with...area and project team meetings as required. Skills: MDR, Regulatory affairs, Medical device , Dental,… more
- Abbott (Pleasanton, CA)
- …+ Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices . + Experience of working within ... + Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements...years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification… more
- Healgen Scientific Limited (Houston, TX)
- … Affairs Specialist is to ensure compliance with regulations and guidelines set by regulatory authorities in the medical devices industry. They play a ... our inception in 2007, we have strived to develop devices that meet and exceed industry standards. Our comprehensive...be marketed or sold. Responsibilities Ensure timely and accurate regulatory submissions of medical device … more
- ConvaTec (Lexington, MA)
- …drugs, biologics/biotechnology and/or medical devices , and continued approved drugs/ medical devices status;** Serve as regulatory representative to ... Education: Life Science Degree or equivalent.** **RAPS Certification preferred.** ** Regulatory /Quality experience in medical devices .** **Experience… more
- Stryker (Mahwah, NJ)
- …certification or Advanced Degree (Masters in Regulatory Affairs) preferred. + Medical device regulatory experience preferred. + General understanding of ... medical devices . + RAC...clinical trials. + Familiarity with FDA, Europe and international medical device regulations. About Stryker Our benefits:… more
- Philips (San Diego, CA)
- …company. + Participates in program/project meetings to provide guidance on the worldwide regulatory requirements for medical devices and external government ... years' Regulatory Affairs experience within FDA regulated, complex Medical Device /Software (SiMD/SaMD) environments, including leadership/guidance on global … more
- Fresenius Medical Center (Waltham, MA)
- …issues and broad design matters. + Understands and interprets US and international medical device regulatory requirements, provides guidance on requirements ... lines. Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets. Develops and… more
- Sanofi Group (Swiftwater, PA)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... team is a globally diverse team supporting the medical device , combination product, digital health and...to internal regulatory processes and procedures for medical devices and combination products. + Engage… more
- Actalent (Franklin, IN)
- …in Engineering (chemical, industrial, biomedical, mechanical) 2. 1-3 years experience working in regulatory for a medical device company 3. Experience ... for orthodontic clients. This position will report directly to the regulatory affairs director. This role involves preparing documentation to support international… more
- LSI Solutions (Victor, NY)
- …international medical device regulations, standards, and guidelines for medical devices . REPORTS TO: REGULATORY COORDINATOR ESSENTIAL FUNCTIONS: ... to gather regulatory intelligence regarding updates to US and international medical device regulations, and supporting Rest-of-World (ROW) regulatory … more
- Medtronic (Northridge, CA)
- …Life** As Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from ... Bachelor's degree and a minimum of 7 years of regulatory experience within the medical device...Medical Devices Directive (93/42/EEC) and European Medical Device Regulation 2017/745 + Experience with… more
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