- Chiesi (Boston, MA)
- …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 ... regulations for drug promotion/advertising and US labeling, and experience interacting with FDA OPDP + Experience with Veeva Vault PromoMats and MedComms, Trackwise,… more
- Integra LifeSciences (Braintree, MA)
- …other product development studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned **Desire Minimum ... other cGMP regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated Industry. + Quality… more
- Teleflex (Chelmsford, MA)
- …Qualification (PQ), and Test Method Validation (TMV) in accordance with ISO, FDA , and corporate guidelines. * Support R&D activities as required utilizing technical ... experience supporting manufacturing, preferably medical devices. * Experience with FDA QSR process and validation documentation requirements a plus. **Specialized… more
- Medtronic (Danvers, MA)
- …Action). Navigate the complexities of various government and industry regulations to include FDA 21 CFR 820, ISO 11135, ISO13485, ISO 11137, ISO 11737, ISO 14644, ... and sterilization internal audit; Industrial EO Sterilization for Medical Devices and CAPA; FDA 21 CFR 820, ISO 11135, ISO 13485, ISO11137, ISO11737, ISO 14644, and… more
- BD (Becton, Dickinson and Company) (Woburn, MA)
- …in production when needed. + Thorough understanding of industry regulations including cGMP, FDA /QSR, and ISO environment for Class III Med devices or equivalent + ... with regulatory and corporate requirements. + Represent department compliance in FDA , internal, corporate, and ISO audits. + Support strategic plant objectives,… more
- Beth Israel Lahey Health (Boston, MA)
- …of adverse events and reports them according to the guidelines of the FDA , sponsoring drug accompany (if applicable) and the IRB. May interact with sponsors ... reports for pharmaceutical company monitors as well as routine audits for the FDA , if applicable. (essential) + Monitors strict adherence to protocols by physicians,… more
- Philips (Cambridge, MA)
- …transactions, including the Anti-Kickback Statute and Safe Harbors, HIPAA, UCC, FDA regulations, antitrust, and state/federal privacy laws. Partner with subject ... compliance with the Anti-Kickback Statute, False Claims Act, HIPAA, and FDA regulations. You bring meaningful experience applying Artificial Intelligence to enhance… more
- Astrix Technology (Devens, MA)
- …+ Conduct internal and supplier audits to ensure compliance with ISO and FDA Quality System Regulation (QSR) standards. + Collect, review, and interpret data for ... a quality, regulatory, or laboratory environment. + Strong knowledge of ISO and FDA Quality System Regulations (QSR). + Proficiency in MS Office applications (Word,… more
- Element Materials Technology (Acton, MA)
- …provides expert environmental monitoring and microbiology USP <797> and cGMP FDA compliance testing solutions to home infusion, pharmacies, hospital pharmacies, and ... human drug outsourcing compounding facilities. The lab is DEA and FDA registered, cGMP certified, and ISO/IEC 17025:2017 accredited **Responsibilities** + Lead and… more
- Integra LifeSciences (Braintree, MA)
- …Action/Preventive Actions (CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned. **DESIRED ... other cGMP regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality… more