- ATR Arena Technical Resources (Lewistown, MD)
- …is seeking experienced Animal Caretakers to support the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). USAMRIID's mission is to ... provide leading-edge medical capabilities to deter and defend against current and emerging biological threat agents. Each Animal Caretakers 3 works within a team to… more
- Oracle (Washington, DC)
- …and industry collaboration around AI in healthcare. Required Qualifications + 8+ years in medical device regulatory affairs or regulatory science. + ... Scientist to provide deep regulatory and scientific leadership for AI-enabled medical device solutions. This role sits within HDI's Regulatory & … more
- Oracle (Montpelier, VT)
- …Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in ... as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions (510k, EU… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Regulatory Affairs Director Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices ...5 years of relevant experience + 2+ years of medical device regulatory experience preferred… more
- Sanofi Group (Morristown, NJ)
- …teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part ... Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across...to internal regulatory processes and procedures for medical devices + Accountable for regulatory… more
- Edwards Lifesciences (Irvine, CA)
- …clinical investigations, etc.). . Monitoring legal developments applicable to the Healthcare Regulatory and medical device spaces. . Other duties ... as needed.** **How you'll make an impact:** The Manager, Regulatory Counsel reports to the Senior Director, Regulatory...negotiating clinical trial agreements and associated contracts in the medical device or pharmaceutical industry or at… more
- Pentax Medical (Montvale, NJ)
- …for a FDA regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices + Experience with reusable ... imaging devices and solutions to the global medical community. Position Opening: Senior Regulatory Affairs...Affairs Specialist Why JOIN Us? We are an established medical device leader that is preparing for… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Duties** + Strategic Leadership and Portfolio Alignment: + Facilitate development of global regulatory strategies for medical devices and digital health ... technologies and data-driven solutions can transform healthcare beyond traditional medical devices . This leadership role leads an...of Regulatory Affairs experience, ideally within the medical device or digital health industries. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Specialist II contributes to the digital transformation in the medical device space. The role focuses on executing regulatory activities, monitoring evolving ... years prior regulatory affairs experience in the medical device industry, or a minimum of...sensitivity to cultural differences. + Familiarity with digital health regulatory frameworks for medical devices … more
- Access Dubuque (Dubuque, IA)
- …Overview** The Metrix Company, a leading manufacturer of single-use medical devices , is seeking a quality-driven Regulatory Affairs Specialist to join our ... development projects for the domestic and international markets for medical devices . Prepares and submits, registrations, licensing,...Biology, Chemistry, or related field with 1-3 years of regulatory affairs, quality, or medical device… more
- Abbott (Pleasanton, CA)
- …discipline + 3+ years of related regulatory submission experience from a medical device and/or pharmaceutical industry + Familiar with relevant US/ EU ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...regulatory requirements for medical devices … more
- Dentsply Sirona (Waltham, MA)
- …team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits ... implements regulatory strategies to obtain and maintain regulatory approvals for medical devices ...experience in regulatory affairs, preferably in the medical device industry. + Experience with leading… more
- Abbott (Pleasanton, CA)
- …Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification (RAC) is a plus + ... + Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements...regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices … more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices . + Strong oral and written communication and presentation ... Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist III. The Regulatory Affairs...wide variety of benefits including, but not limited to: Medical , Dental, Vision, PTO, up to 5% 401(K) match… more
- Kelly Services (Norcross, GA)
- … Regulatory Affairs (Transfusion).** Principal, Regulatory Affairs - IVD / Medical Devices Location: Norcross, GA Industry: Medical Devices ... Principal, Regulatory Affairs professional to manage pre-market regulatory activities for medical devices ,...* Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulations, MDSAP, and exposure to… more
- Dentsply Sirona (Sarasota, FL)
- …and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices , including 510(k) submissionsand ... current with regulatory requirements and updates affecting medical devices + Fosters professional interactions with...experience in regulatory affairs, preferably in the medical device industry + Experience with … more
- Abbott (St. Paul, MN)
- …join our Global Regulatory Operations team and lead portfolio management of regulatory programs across medical device business units, international ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- … process. + 3+yearof Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of labeling, promotional, and ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Stryker (Redmond, WA)
- …(Masters in Regulatory Affairs). + Previous experience with US Class II/III medical devices . + Experience authoring regulatory submissions for product ... based **Hybrid** in **Redmond, Washington.** As part of the Medical Regulatory Affairs team, you will work...team, you will work with the team to maintain medical devices on the market and ensure… more
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