- Hologic (Marlborough, MA)
- …representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a ... assess risks to Hologic products, and manage these risks according to established quality procedures. + Participate in continuous improvement of our Secure by Design… more
- Catalent Pharma Solutions (Chelsea, MA)
- **Manager, Quality Control (Clinical and Tech Transfer Team)** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing ... North America. Catalent Pharma Solutions is hiring a Manager, Quality Control (QC) who is a key analytical leader...regulatory audits preferred, but ability to apply applicable regulations ( FDA , EU, Japan, USP, ICH, etc.) in a phase… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions. ... Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate… more
- Philips (Cambridge, MA)
- …development projects, ensuring our state-of-the-art Ultrasound Products meet FDA , and other governmental agency/notified body Regulatory Compliance ... with the RA management. + Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the following duties: Write Validation documents per Food Drug Administration ( FDA )/Company guidelines; draft Specification documents and Validation Plans (VPs) for ... for new and existing equipment or procedures in accordance with company and FDA regulations; define and own all necessary change control objectives to decommission… more
- Sanofi Group (Cambridge, MA)
- …and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion ... market access, and press materials. Submits materials on form FDA 2253 when applicable. + Provides US RA AdPromo...a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least… more
- Sanofi Group (Cambridge, MA)
- …action, competitively positions assigned products and is consistent with applicable FDA regulations and company policies for advertising and promotion of ... Provision of competitively positioned promotional materials that comply with applicable FDA and corporate regulations, policies and guidance + Analyze whether… more
- Hologic (Marlborough, MA)
- Director, Internal Audit Marlborough, MA, United States Are you a seasoned quality and compliance professional with a passion for driving excellence in regulated ... and play a pivotal role in ensuring the effectiveness of our global Quality Systems. In this critical leadership position, you will define, implement, and monitor… more
- Sanofi Group (Cambridge, MA)
- …and mitigation strategies) systems are operating efficiently and in compliance with FDA regulations, while also enabling smooth data flows between various systems ... processes, and meet the business needs with the agreed quality of service. + Responsible throughout the entire project...while adhering to regulatory compliance (21 CFR Part 11, FDA REMS guidelines). + Work closely with QA and… more
- Abbott (Burlington, MA)
- …and providing information on product complaints to various teams (eg Regulatory, Quality Engineering). The other role of the Post Market Surveillance Analyst is ... report needs to be filed with various global regulatory agencies (eg, FDA , European Competent Authorities) and sends reports within required timeframes, consulting… more