- Merck (West Point, PA)
- …and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a ... frictionless flow of data from source systems to regulatory documentation. Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, … more
- J&J Family of Companies (Santa Clara, CA)
- … agencies. + Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory ... company + Review and approve advertising and promotional materials to ensure regulatory compliance + Evaluate import/export requirements + Identify emerging… more
- Envista Holdings Corporation (Brea, CA)
- …by relevant authorities, assess their impact on the organization, and provide timely regulatory guidance and support to ensure compliance . + Develop and maintain ... review and evaluation of product, manufacturing, and labeling changes to determine regulatory reporting requirements and ensure ongoing compliance . + Follow… more
- Atlantic Health System (Morristown, NJ)
- …and ambulance agreements, and home health and hospice agreements, assuring legal and regulatory compliance . Serve as a primary resource for the interpretation of ... on regulatory issues, including fraud and abuse issues, HIPAA compliance , EMTALA, Medicare and Medicaid compliance , licensure issues, pay-to-play issues,… more
- Abbott (Alameda, CA)
- …Asia, navigating complex regional regulations. + Compliance and Oversight: Ensure compliance with global regulatory standards (eg, FDA, EMA, ISO 13485, EU ... Collaboration: Partner effectively with cross-functional teams (eg, R&D, product, clinical , marketing) to integrate quality and regulatory considerations… more
- Philips (Chicago, IL)
- …development is ideal. + Your skills include knowledge and experience with regulatory compliance and engineering standards related to safety like radiation ... oversees worldwide submissions and post-market surveillance, and ensures quality and compliance with relevant regulations. They provide regulatory guidance on… more
- Abbott (Alameda, CA)
- …requirements + Review and approve advertising and promotional items to ensure regulatory compliance . **Required Qualifications** + Bachelor's Degree. + Minimum 5 ... approve them. + Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture. + Anticipate… more
- Surgery Care Affiliates (AL)
- …key performance indicators (KPIs) relevant to quality, patient safety, accreditation and regulatory compliance and impact on SCA vitals, goals, strategic plan, ... including: + Collaborates with other departments such as legal, regulatory compliance , human resources, etc. to ensure...+ Develop, update, and maintain patient safety, quality, and/or clinical compliance programs, play books, tool kits,… more
- Sanofi Group (Morristown, NJ)
- …timelines for clinical trial initiation. + Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission ... **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the...internal business partners, including but not limited to the clinical development teams, commercial and GRT for assigned projects.… more
- Oura (San Francisco, CA)
- …and international registrations. + Partner with science, data science, engineering, clinical , marketing, and legal teams to integrate regulatory requirements ... heart health tracking. We view Oura Ring as a clinical grade device in a consumer package rather than...of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play a key… more