- Oracle (Phoenix, AZ)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Teleflex (Morrisville, NC)
- …in a science or engineering field, or equivalent work experience. 5+ years of Medical Device Regulatory Affairs experience, domestic and international. ... Senior Regulatory Affairs Specialist Date: Dec 2,...- The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose… more
- Globus Medical, Inc. (Audubon, PA)
- …experience in medical device industry or equivalent, preferably within orthopedic medical devices ; Regulatory Affairs experience is a plus. ... 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… more
- Abbott (Minneapolis, MN)
- …microbiology, etc.), math, engineering, or medical fields. Master's degree in Regulatory Affairs . Regulatory experience with capital equipment including ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of 10 years of Regulatory Affairs experience, ideally within the medical device or digital health industries. Minimum of 3 years focused on ... medical devices . This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies for digital… more
- Olympus Corporation of the Americas (Westborough, MA)
- …in engineering or life sciences required. Minimum of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of ... to the digital transformation in the medical device space. The role focuses on executing regulatory...demonstrated sensitivity to cultural differences. Familiarity with digital health regulatory frameworks for medical devices … more
- West Pharmaceutical Services (Exton, PA)
- …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...with 5+ years; Master's degree/PhD with 3+ years of medical device , pharmaceutical or regulatory … more
- Dentsply Sirona (Waltham, MA)
- …a plus. Years and Type of Experience 5(+) years of experience in regulatory affairs , preferably in the medical device industry. Experience with leading ... regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This...MDR). Experience with software as a medical device , AI and/or medical devices … more
- Olympus Corporation of the Americas (Westborough, MA)
- …BS or comparable required. Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device or digital health industries. ... including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies. Provide regulatory guidance, compliance… more
- Abbott (Minneapolis, MN)
- …scientific affairs function. Preferred Qualifications 4+ years of related regulatory submission experience from medical device , pharmaceutical, or ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines.... regulatory affiliates. Compile, prepare, review and submit medical device submissions to regulatory … more
- Medtronic (Minneapolis, MN)
- …in the medical device industry, particularly with Class III medical devices (PMA). Regulatory Submission Expertise: Proven experience preparing and ... connected, compassionate world. A Day in the Life SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading...manager. To Be Successful in This Role Medical Device Experience: Direct experience… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …staff. Minimum Requirements: Bachelor's degree Minimum 5 years of strong Regulatory Affairs experience in the medical device and/or in vitro diagnostic ... This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy...Board of Pharmacy, and Environmental requirements Working knowledge of medical device stand-alone software, device … more
- Carrier (Beverly, MA)
- …in regulatory affairs 2 years of experience with hardware, IoT, medical devices , or regulated electronics. 2 years of experience managing regulatory ... sustainability, and global impact. About this role As the Regulatory Affairs & Compliance Lead at Sensitech...for medical devices ); IEC 60601 ( Medical electrical equipment safety) Lead regulatory interface… more
- J&J Family of Companies (Raynham, MA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs ... We are searching for the best talent for a Regulatory Affairs Specialist II to support our...in a highly regulated industry required , preferably in medical device (1+ years with Advanced Degree).… more
- Teleflex (Reading, PA)
- Sr. Regulatory Affairs Associate Date: Nov 24,...or medical technology. Minimum 2 years of medical device regulatory experience or ... a difference in patients' lives. Position Summary The Sr Regulatory Affairs (RA) Associate will be responsible...Canada License applications, European Union (EU) Medical Device Regulations (MDR) submissions, and other regulatory … more
- Grifols Shared Services North America, Inc (Durham, NC)
- …related to licensing activities, Source Plasma collection and medical device regulations. Maintain up-to-date knowledge of regulatory requirements and ... and services in more than 110 countries and regions. Summary: The Regulatory Affairs Surveillance Specialist will determine and execute actions necessary… more
- ICON Clinical Research (Raleigh, NC)
- …consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices , regulatory intelligence, due ... Senior Manager, Regulatory Affairs - IVD ICON plc...role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of Innovative… more
- Sanofi Group (Framingham, MA)
- …framework, providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle. ... we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as… more
- BD (Becton, Dickinson and Company) (Tempe, AZ)
- …will also prepare regulatory submissions required to market new or modified medical devices in global markets. The RA Specialist is able to interpret ... Job Description Summary The Regulatory Affairs (RA) Specialist will provide...a minimum of one year of experience in a Regulatory role within the Medical Device… more
- Fresenius Medical Care North America (Lawrence, MA)
- …equipment experience desirable Strong collaboration skills and experience working with Clinical, Medical Affairs , and Regulatory teams. Proven ability to ... , this individual works closely with cross-functional partners-including Clinical Education, Medical Affairs , Product Management, Patient Marketing, and Sales-to… more
