- Actalent (San Clemente, CA)
- …+ 5+ years in the medical device industry focusing on biocompatibility, regulatory compliance, or quality assurance. + Understanding of specific biological ... Job Title: QA SpecialistJob Description The Quality Assurance Specialist will lead the evaluation of...in gap analysis, risk assessment, and remediation planning for regulatory audits or submissions. + Familiarity with FDA… more
- Wolters Kluwer (Chicago, IL)
- …engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. ... and managing the software development plan and partnering with engineering, quality , and regulatory team members to aligning the process with agile and lean… more
- Danaher Corporation (Miami, FL)
- …industry. Interns will work closely with cross-functional teams including R&D, Quality / Regulatory Assurance, and Technical Support. This position reports to ... FDA , EU, IVDR, ISO, CLP/GHS, and other countries' regulatory requirements. . Support the management of labeling change...for detail and accuracy. . Eagerness to learn about regulatory affairs, quality systems, and the diagnostics… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …+ **Governance & Compliance** + Ensure all training programs meet global regulatory requirements and internal quality standards. + Monitor training effectiveness ... biotech, or healthcare industry. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to… more
- Takeda Pharmaceuticals (Boston, MA)
- …track record in dealing with international regulations and policies setting processes of major regulatory agencies (eg US FDA , EU, PMDA, NMPA, WHO). + Actively ... R&D (Discovery and Therapeutic area units - TAUs), GRA, GMS, Global Quality and Commercial. **Accountabilities:** + Develop innovative strategies for the management… more
- Takeda Pharmaceuticals (Boston, MA)
- …will represent Small Molecule Drug Substance in forums with partners including Regulatory , Quality , Analytical Services, Supply Chain, R&D, and functional ... troubleshooting and optimization. + Author and/or review key CMC and quality deliverables, such as: + protocols, validation reports, methods, technology transfer… more
- Sanofi Group (Waltham, MA)
- …affairs plans, studies and submissions activities (when applicable), including quality , relevance to external stakeholders (eg regulatory authorities, ... success. + Contribute with project team members (ie: clinical, pharmacovigilance, regulatory , ) to gain Health Authorities acceptance of the plans, accountable… more
- Lilly (Indianapolis, IN)
- …of cGMP requirements in medical device manufacturing. + Understanding of basic requirements of regulatory agencies such as the FDA , DEKRA, and OSHA. + Excellent ... of leaders, you'll influence and implement our organizational agenda, business priorities, and quality objectives to drive success down to the floor level. Join us… more
- Chase Plastics (Clarkston, MI)
- …and now - was to do what big distributors would not: provide quality specialty, engineering and commodity thermoplastics for small- to medium-sized applications - ... PURPOSE OF POSITION: To manage and administrate all customer requests for regulatory documentation. Responsible for the overall maintenance and organization of … more
- Envista Holdings Corporation (Orange, CA)
- …improve product performance, reliability, and clinical outcomes, while maintaining compliance with FDA , ISO 13485, and other regulatory standards. Design & ... with cross-functional teams including product management, project management, manufacturing, quality assurance, regulatory affairs, and customer support to… more