- Fresenius Medical Center (Lawrence, MA)
- …to ensure accuracy, relevance, and alignment with treatment protocols and regulatory standards. Coordinate with Product Marketing, Value Stream, and the ... products Ensure all materials are reviewed and approved through appropriate regulatory and medical review processes. **PHYSICAL DEMANDS AND WORKING CONDITIONS:** The… more
- Sanofi Group (Cambridge, MA)
- …patient safety/pharmocovigilance, patient focused drug development, portfolio management, global regulatory and digital partners to foster innovation and ensure best ... digital biomarkers.Cultivaterepresentation of Sanofi at key industry conferences (eg DIA, FDA industry workshop) and academic forums. + Establish and maintain… more
- Jabil (Clinton, MA)
- …environment, command of medical device design controls and related regulatory requirements, a penchant for maintaining detailed documentation throughout all ... high-volume injection molding, automation - Alignment with Design Controls and Regulatory Requirements - Test Method Development - Design Verification and Validation… more
- Takeda Pharmaceuticals (Lexington, MA)
- …systems like COMOS and Veeva. + Ensure compliance during audits, author regulatory filings, and support safety inspections through comprehensive data preparation. + ... experience and accomplishments. + Proficiency in cGMP Engineering within FDA -regulated industries (pharmaceutical or biotechnology) and strong understanding of Good… more
- Hologic (Marlborough, MA)
- …Deep understanding of Quality Management Systems (QMS), including ISO 13485 and FDA QMSR regulations. + Expertise in root cause analysis, CAPA, complaint ... devices. + Proven track record in complaint investigations, CAPA processes, and regulatory compliance. + Experience in a leadership or management role, with direct… more
- Sanofi Group (Cambridge, MA)
- …and presentations to support project milestones, publications, patent filings, and regulatory (IND/CTA) filings + Present project data packages at governance ... biodistribution studies in rodents or NHPs + Experience drafting regulatory documents to support IND or CTA applications with...support IND or CTA applications with agencies like the FDA and EMA + Experience managing studies at CROs… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …institutions for clinical and non-clinical Dana-Farber research projects 3. Identify regulatory compliance, legal, intellectual property, and other risks in the ... with applicable laws, regulations, Institute's policies, and guidelines. + Identify regulatory compliance, legal, intellectual property, and other risks in the… more
- System One (Harvard, MA)
- …making of non-conformance through a deep understanding of Quality Systems Regulatory expectations + Reviews and approves Quality, Quality Control, Validation and ... as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements. + Ability to coach… more
- Charles River Laboratories (Cambridge, MA)
- …+ Ensures compliance and documentation with all institutional and regulatory protocols, policies, and guidelines. + Identify process inefficiencies, streamline ... compliance with all internal (IACUC) and external (USDA-APHIS, PHS-OLAW,) regulatory agencies as well as AAALAC International accreditation. +...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Hologic (Marlborough, MA)
- …In this role, you'll execute activities to ensure compliance with regulatory standards and Quality Management System requirements, conduct technical reviews, and ... manufacturing practices (eg, electronics, plastics, metals). + Strong understanding of regulatory standards like ISO-13485, ISO-14971, ISO-9001, CFR 820, and FDA… more