- 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
- Chemours (Frankfort, KY)
- …outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer ... at a time. Chemours is seeking a **Product Stewardship & Regulatory Expert - Medical Applications** to join our growing Advanced Performance Materials (APM)… more
- J&J Family of Companies (Spring House, PA)
- …by the Company. **We are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology.** **Purpose:** + Able to function as a ... experience is required. + At least 8 years of relevant clinical/ regulatory medical writing experience is required. + Experience in project management and… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date: Jun 11, 2025 Location: Exton, Pennsylvania, US Department: Regulatory ... and planet through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department … more
- System One (Malvern, PA)
- Job Title: Director of Regulatory and Medical Affairs Location: Malvern, PA Type: Direct Hire Essential Duties/Responsibilities: + Manage Regulatory and ... sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. + Strong understanding and… more
- Caldera Medical (Westlake Village, CA)
- …- To Improve the Quality of Life for Women! In your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies ... submit and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU… more
- J&J Family of Companies (Santa Clara, CA)
- …of America **Job Description:** Johnson & Johnson is hiring for a **Sr. Manager, Regulatory Compliance - Shockwave Medical ** to join our team located in **Santa ... of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for … more
- Sanofi Group (Cambridge, MA)
- …device regulatory activities associated with Sanofi's combination product and medical device portfolio in the Specialty Care R&D and commercial product ranges. ... representative in project/product teams + Develop innovative and sustainable medical device regulatory strategies + Provide regulatory guidance and advice… more
- Abbott (Plymouth, MN)
- …+ 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
- 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
- Cardinal Health (Phoenix, AZ)
- …+ 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 (Santa Clara, CA)
- …as other applicable EU regulations as they relate to Class III implantable medical devices is required. Working knowledge of regulatory requirements for Japan, ... regulatory submission experience, with substantial knowledge of US FDA Medical Device Regulatory Requirements for class III medical devices and EU … more
- Edwards Lifesciences (Irvine, CA)
- …potential legal risks. This role requires deep knowledge of global medical device-industry, including the regulatory landscape, authorities and frameworks, ... role will provide high-quality guidance and support to Edwards' leaders on medical device commercial, clinical, regulatory , quality and reimbursement related… more
- Medtronic (Irvine, CA)
- …experience + Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs **This is not a remote position** **Nice To Have** ... + 4 years of experience in medical device regulatory affairs + Excellent technical knowledge of medical products and understanding of relevant procedures,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …self. Become a **maker of possible** with us. **Overview** As Staff Specialist, Regulatory Affairs, you will develop and implement medical device regulatory ... a related field + Minimum 3 years of practical experience regulatory affairs, with a focus on medical device systems + Knowledge of international regulatory … more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Stryker (Weston, FL)
- …of experience in an FDA regulated industry + 2+ years of experience in medical device regulatory affairs + Thorough understanding of FDA, Europe, and ... international medical device regulations + Experience drafting regulatory submissions for product approval **Preferred** + RAC certification or Advanced Degree… more
- Hologic (Marlborough, MA)
- …impact in the medical device industry? Hologic is seeking a **Senior Regulatory Compliance Specialist** to lead the charge in ensuring our corporate policies and ... we'd love to hear from you! **Knowledge** + Deep understanding of global medical device regulatory frameworks and Quality Systems Management requirements. +… more
- Medtronic (Minneapolis, MN)
- …profile_ + Bachelor's degree in a technical discipline + Minimum 4 years of medical device regulatory experience with Bachelor's degree + Or minimum 2 years ... of medical device regulatory experience with an advanced degree **Nice To Have** + Experience working in regulated environment, including involvement with … more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
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