- Actalent (Springfield, MO)
- …pathogens, and spoilage organisms. + Familiarity with ISO accreditation and regulatory requirements ( FDA , USDA, AOAC methods). + Excellent leadership, ... The manager will provide technical leadership, supervise laboratory staff, maintain quality standards, and ensure regulatory compliance with industry and… more
- Actalent (St. Paul, MN)
- …and components for medical devices. You will work cross-functionally with R&D, Quality , Regulatory , Product Management, and Manufacturing teams to ensure ... risk management activities, including FMEA and fault-tree analysis, ensuring compliance with regulatory and quality standards. + Support design transfer to… more
- University of Miami (Miami, FL)
- …for someone with high attention to detail, proven experience in managing regulatory documentation and submissions to entities such as the Institutional Review Board ... (IRB) and the Food and Drug Administration ( FDA ). This role is essential for ensuring compliance and...the integrity of our clinical research efforts. + Complete regulatory IRB submissions, continuing reports, and modifications of protocols,… more
- BeOne Medicines (Pennington, NJ)
- …drug preclinical, clinical and commercial requirements. + Familiarity with EMA and FDA regulatory requirements for submissions. + Effective communication, oral ... This position involves close collaboration with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory , Process Development… more
- Lundbeck (Deerfield, IL)
- …for a rare disease + Past responsibility for managing IIT process + FDA regulatory knowledge and direct exposure **TRAVEL:** + Willingness/ability to travel ... to inform and shape medical strategy + Develop and communicate high- quality medical content, compelling scientific narratives, engaging congress and field materials… more
- DEKA Research & Development (Manchester, NH)
- …Practices; meets QMS requirements; and complies with US Food and Drug Administration ( FDA ) regulations / other regulatory requirements. + Identify and make sound ... handling investigations, medical device reporting, or product analysis. + Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical… more
- Lilly (Indianapolis, IN)
- …projects. * Follow all GMP, and other regulatory requirements. Participate in quality initiatives and audits. Compliance to FDA , EMEA, DEA, OSHA, IDEM, and ... Strong interpersonal and communication skills. * Solid understanding of quality and corporate policies. * Solid understanding of the...understanding of the importance of and basic requirements of regulatory agencies such as the FDA , EMEA,… more
- Penn Medicine (Philadelphia, PA)
- …self and assigned area(s) are compliant with all applicable federal, state, and local regulatory standards (ex OSHA, TJC, DOH, FDA , HIPAA, etc.) + Oversees the ... maintaining a patient/customer focus, supports the delivery of high quality care, shares a passion for patient and customer...Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA,… more
- Abbott (Sturgis, MI)
- …experience + Experience utilizing project planning and execution tools + Knowledge of FDA - 21 CFR and other regulatory requirements for Infant Formula ... in ensuring major objectives are met. Major objectives include: assuring regulatory compliance, meeting production schedules, creating and maintaining a high level… more
- PCI Pharma Services (Bedford, NH)
- …interpersonal, oral, and good written communication skills. + Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices. + Excellent ... Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems. + Lead major projects and tracking spending...control system. + Experience working in a GMP and FDA regulatory environment for drugs and/or medical… more