- Actalent (Agoura Hills, CA)
- …and audits in a timely and professional manner. + Maintain up-to-date knowledge of global regulatory requirements and assess their impact on current and future ... and country-specific submissions. + Experience working with Notified Bodies and global regulatory agencies for product approvals and compliance matters.… more
- Edwards Lifesciences (Irvine, CA)
- … strategic plans + Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and ... Class II and/or Class III devices + Full knowledge and understanding of global regulatory requirements for new products or product changes. + Full knowledge of… more
- Bio-Techne (Austin, TX)
- … regulatory submissions. + Research the history of a product and advise on global regulatory strategy. + Assist with regulatory responses and interactions ... by regulatory authorities. + Communicate clearly and effectively with global regulatory authorities. + Provide input into regulatory functions and… more
- Merck (North Wales, PA)
- …business processes and systems. + Development, communicate, implement and maintain detailed, global regulatory strategies for submission and approval of complex ... packages, post-approval submissions/variations, according to defined timelines. + Provide detailed, global regulatory assessments for changes to device and… more
- Edwards Lifesciences (Irvine, CA)
- …to management + Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for ... submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions **What you will need (Required):**… more
- Sanofi Group (Morristown, NJ)
- …partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects + Liaises with clinical, ... pharmaceutical/biotechnology industry experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and/or global ) especially in… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …skills, and the ability to multi-task disparate projects. * Knowledge of global Regulatory Affairs requirements, regulations, and standards. * Excellent ... * Support business export control (BEC) listing of products for global release per Regulatory Affairs requirements. * Review and approve labels, labeling, and… more
- Stryker (Mahwah, NJ)
- …**Senior Manager, Regulatory Affairs** , you will lead and coordinate global regulatory activities including regulatory strategies and health authority ... We are currently seeking a **Senior Manager, Regulatory Affairs** to join our Joint Replacement Division...global medical device regulations including direct experience with regulatory submissions associated with US and EU Class II/III… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …submissions, document management, and compliance tracking and to ensure adherence to global regulatory standards. + Collaborate with Quality Management team(s) ... Development & Regulatory Compliance domain, ensuring alignment to the overall Global IT technology strategy and roadmap. + Supports the Head of Enterprise… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will provide regulatory ... and life cycle of Rhythm products. This role reports into the Director, Global Regulatory Affairs. Responsibilities and Duties + Act as the Global … more