- Xcelerate Solutions (Frederick, MD)
- Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking a Senior program analyst who will support Joint Program Executive ... Office for CBRN Defense (JPEO-CBRND) Medical Regulatory and Acquisition Strategy (MRAS) team. In this role, you will support the MRAS Team of medical … more
- Oracle (Montpelier, VT)
- …success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with ... as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions (510k, EU Tech… more
- ThermoFisher Scientific (Greenville, NC)
- …of clinical research. Your expertise will enable us to deliver flawless Regulatory Medical Writing documents, such as protocols, CSR, Investigator Brochures, ... to 8+ years). + Experience in managing and directing complex Regulatory medical writing projects required + Experience working in the pharmaceutical/CRO industry… more
- ThermoFisher Scientific (Greenville, NC)
- …**Environmental Conditions** Office **Job Description** Join us as a Program Manager within our Regulatory Medical Writing team where you will make an Impact at ... excellence that makes a real difference in organizational performance. As a Regulatory Medical Writing Program Manager, you will lead client programs with high… more
- Oracle (Washington, DC)
- …Intelligence is hiring a Lead Regulatory Scientist to provide deep regulatory and scientific leadership for AI-enabled medical device solutions. This role ... sits within HDI's Regulatory & Medical Device organization. You will serve as a...a reviewer and as a submitter - bringing real-world regulatory judgment to HDI's global medical device… more
- Stryker (Redmond, WA)
- …** **Division** to be based **Hybrid** in **Redmond, Washington.** As part of the Medical Regulatory Affairs team, you will work with the team to maintain ... We are currently seeking a **Senior Regulatory Affairs Specialist** to join our ** Medical... Affairs). + Previous experience with US Class II/III medical devices. + Experience authoring regulatory submissions… more
- Globus Medical, Inc. (Audubon, PA)
- …experience in medical device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus. + Excellent ... At Globus Medical , we move with a sense of urgency...lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining… more
- LSI Solutions (Victor, NY)
- …gather regulatory intelligence regarding updates to US and international medical device regulations, and supporting Rest-of-World (ROW) regulatory approvals, ... that govern the design, development, manufacturing, and distribution of our medical devices. REPORTS TO: REGULATORY COORDINATOR ESSENTIAL FUNCTIONS: Level… more
- Sanofi Group (Morristown, NJ)
- …GRA Device organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory ... Vaccine Medical Device and Combination Product team you'll drive global regulatory strategies for medical device and combination products, collaborate with… more
- Cardinal Health (Helena, MT)
- …+ Nonclinical Development and Consulting + Clinical Development and Research + Medical Writing + Regulatory Publishing + Dossier Services + Submission ... & Filing + Quality Review Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance +… more
- Abbott (Pleasanton, CA)
- …+ Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus + Experience with ... device regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and… more
- Cardinal Health (Mansfield, MA)
- Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate will ... provide regulatory support on a range of medical devices. Job responsibilities include regulatory lead...range of medical devices. Job responsibilities include regulatory lead for change development projects, new product development,… more
- Cardinal Health (Waukegan, IL)
- Cardinal Health is seeking a Senior Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate will ... provide regulatory support on a range of medical devices. Job responsibilities include support of change development projects, new product development, change… more
- Terumo Aortic (Sunrise, FL)
- …field) from an accredited college or university and 3 years direct experience in medical device regulatory affairs + Minimum 5 years direct experience in ... medical device regulatory affairs if no degree. + Knowledge of US and European regulatory processes, including Class III is strongly preferred. + Preferred… more
- West Pharmaceutical Services (Exton, PA)
- …regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's Transfer Devices with ... an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner + Author and review US, EU, Japan,… more
- Teleflex (Maple Grove, MN)
- …a science or engineering field, or equivalent work experience. * 5+ years of Medical Device Regulatory Affairs experience, domestic and international. 3 years of ... Senior Regulatory Affairs Specialist **Date:** Jan 9, 2026 **Location:**...:13226 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- West Pharmaceutical Services (Exton, PA)
- …and planet through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department ... requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and safety… more
- Teleflex (Wyomissing, PA)
- …personnel to support 510(k)s, Canada License applications, European Union (EU) Medical Device Regulations (MDR) submissions, and other regulatory deliverables, ... or medical technology. * Minimum 2 years of medical device regulatory experience or equivalent. * Basic experience with preparing 510(k) submissions,… more
- West Pharmaceutical Services (Exton, PA)
- …Bachelor's with 5+ years required; or + Master's degree/PhD 2+ years medical device regulatory experience required **Preferred Knowledge, Skills and Abilities** ... Sr. Specialist, Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date:...legislations (eg California Prop 65, RoHS, Conflict Minerals, EU Medical Device Regulation) for all West global product portfolios… more
- ICON Clinical Research (NC)
- …development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices, regulatory intelligence, due diligence, ... Senior Manager, Regulatory Affairs - IVD ICON plc is a...role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of Innovative… more