- Olympus Corporation of the Americas (Westborough, MA)
- …support Regulatory Affairs' efforts in creating submission materials for various regulatory domains including FDA , PMDA, and EU-MDR. **Job Duties** + Advise ... project teams, Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs, etc. + Independent organizational and time… more
- Integra LifeSciences (Braintree, MA)
- …equivalent with 1+ years of experience in a medical device, pharmaceuticals, Quality / Regulatory Compliance, or other regulated industry. + Familiarity with ... application of FDA and/or ISO quality standards in a government regulated industry. + Moderate computer competence, including experience with database and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide ... global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality...requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience… more
- Hologic (Marlborough, MA)
- …quality , we want to hear from you! **Knowledge:** + In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + ... Expertise in compliance issues and regulatory expectations. + Advanced knowledge of Quality ...and regulatory expectations. + Advanced knowledge of Quality Management Systems and risk-based approaches. + Familiarity with… more
- Medtronic (Newton, MA)
- … and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO ... + Advanced degree in a relevant field. + Certification in quality systems or regulatory affairs (eg, Six Sigma, ASQ, or similar). **\#LI-MDT** **Physical Job… more
- Staples (Framingham, MA)
- …to changing regulatory and consumer requirements. + Preparing and delivering quality and safety reports and executive presentations. + Serving as company lead ... OSHA, etc.). **What's needed- Basic Qualifications** : + Bachelor's degree in Quality Management, Engineering, Supply Chain, Regulatory Affairs, or related… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Practice) compliance + Ethics and Compliance + Pharmacovigilance + Partner with Quality , Regulatory , R&D, Manufacturing, Supply Chain, and IT to ensure ... GxP compliance, Ethics & Compliance, and Pharmacovigilance, ensuring alignment with regulatory requirements and business objectives. This strategic leader will be… more
- TE Connectivity (Medway, MA)
- …all activities performed within TE Medical + Leads and supports audits from external regulatory agencies ( FDA , BSI, JPAL) and customers and to lead preparation ... Quality Manager Posting Start Date: 11/7/25 **At TE,...Design History Files (DHF) for new products and ensures regulatory compliance. + Leads and demonstrates expertise in the… more
- ThermoFisher Scientific (Bedford, MA)
- …Impact** Leading quality efforts for PPA, the Director reports to the VP of Quality & Regulatory at BPG. They drive a customer-focused quality culture ... (Mon-Fri) **Environmental Conditions** Office **Job Description** **Job Description: Director, Quality - Purification & Pharma Analytics (PPA)** **How You'll Make… more
- Hologic (Marlborough, MA)
- …+ Strong understanding of Quality Management Systems (QMS), CAPA processes, and regulatory requirements, including ISO 13485 and FDA QMSR. + Familiarity with ... Quality Engineer 2 Marlborough, MA, United States Are...and sustaining engineering. + Proven track record of supporting regulatory audits and maintaining audit-ready documentation. + Preferred: Experience… more