- Chiesi (Boston, MA)
- …social media, press releases, and talking points + Ensures regulatory compliance while effectively managing business risks + Understands global promotional ... published by OPDP, and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing Information are reflected in… more
- Abbott (Westford, MA)
- …schedules all while enhancing product quality and meeting all compliance requirements. **MAIN RESPONSIBILITIES** + Develop, establish, and maintain strategic ... within Manufacturing as the foundation of the culture. + Ensure quality and compliance is of the highest priority within manufacturing and that product meets all… more
- Fresenius Medical Center (Lawrence, MA)
- …risk to users and patients as well as regulatory and corporate SOP compliance . . Reviews and approves design control deliverables along the product development ... and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning and implementation of risk… more
- ThermoFisher Scientific (Plainville, MA)
- …operations. The manager collaborates closely with GMP and Operations to uphold compliance and product integrity. **Key Responsibilities:** Lead a team of quality ... or cell and gene therapy sectors + Consistent record handling regulatory inspections ( FDA , EMA, Health Canada) + Proven success in building and leading impactful… more
- Takeda Pharmaceuticals (Boston, MA)
- …(SDTM and ADaM), medical terminology, clinical trial methodologies to ensure the compliance with regulatory agencies and data reporting standards; create and review ... SDTM and ADaM datasets as per CDISC IG (Implementation guide) and FDA TCG (Technical conformance Guide); contribute to process improvement initiatives for creating… more
- Biomat USA, Inc. (Fall River, MA)
- …employees and supervise donor flow. * Learn and maintain thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration ... ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health...standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and… more
- Eliassen Group (Westborough, MA)
- …strength of materials, FEA, risk analysis). . Maintain strong working knowledge of FDA 21 CFR 820, ISO 14971, IEC 60601, GMP, and related standards. **Experience ... Proficient in Geometric dimensioning and tolerance . Strong working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as… more
- Charles River Laboratories (Wilmington, MA)
- …customer training, and product validations. * Responsible for completing all service and compliance documentation as required by company policy, cGMP and FDA . * ... proudly supported the development of ~85% of the drugs approved by the FDA in 2019. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity… more
- Integra LifeSciences (Braintree, MA)
- …Process Validation, or other studies as deemed necessary. + Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal ... development and sustaining/remediation projects. + Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements. + Identify and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …analysis, etc. required for new and existing products. + Working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they ... in Geometric dimensioning and tolerance. + Must have working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they… more