- Unither Pharmaceuticals (Rochester, NY)
- …necessary controls and mitigation methods. Develops, writes, and executes qualification protocols ensuring FDA 21 CFR part 11 and Annex 11 compliance as well as ... change and adapt project scope creep and change in timelines. Understanding of FDA requirements for validation. The ability to analyze and interpret data. In depth… more
- Katecho (Des Moines, IA)
- …System (QMS), ensuring alignment with both internal and external standards, including FDA , EMA, ICH, and GMP. + Regulatory Compliance: Ensure compliance with ... applicable pharmaceutical regulations ( FDA , EMA, ICH, etc.) and work closely with regulatory agencies during audits, inspections, and submissions. + Quality Control… more
- Hologic (Newark, DE)
- …recommending actions. + Participate in internal and external audits, including FDA inspections and supplier audits. + Support monthly Quality Investigation Review ... + 2-5 years' experience in engineering, ideally within an FDA -regulated industry. + Experience in root cause analysis or...is beneficial. **Skills & Attributes:** + Working knowledge of FDA Quality System Regulations, ISO 13485, EU Medical Device… more
- Hologic (San Diego, CA)
- …in supporting quality activities related to Design Control efforts in accordance with FDA , ISO, and other IVD regulations. You will also support the company's ... quality system activities and design comply with the FDA 's Quality System Regulations (QSRs), ISO 13485, and applicable...knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties & Responsibilities** + ... with all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. + Maintains research practices using Good… more
- United Therapeutics (Silver Spring, MD)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... project teams Preferred Qualifications + 5+ years of experience in the FDA regulated pharmaceutical manufacturing environment + SAP Certification + Knowledge and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports ... point of contact with health authorities, leads and manages FDA meetings and/or other regional HA meetings as appropriate....of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. +… more
- Abbott (Altavista, VA)
- …laws and regulations, inclusive of US Food and Drug Administration ( FDA ) regulations, Occupational Safety & Health Administration (OSHA) regulations, Good ... security programs to ensure risk mitigation and compliance. Ensure compliance with the FDA Intentional Adulteration Rule as the owner of the site's Food Defense… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …identify and respond to signal analysis, and submit to regulatory agency ( FDA /Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance ... regulatory norm + Anchor drug safety regulatory inspection in US ( FDA regulatory agencies),participate in audits and provide support in external audits. Responsible… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …skills, excellent customer service abilities, and meticulous documentation practices in an FDA -regulated environment. This is a remote role with overnight hours to ... organizational capabilities + Ability to follow procedures in an FDA -regulated environment **Required Qualifications** + High School Diploma (minimum education… more