- Rhythm Pharmaceuticals (Boston, MA)
- …global biotech/pharma organization. Experience with rare diseases and international regulatory environments preferred + BA/BS degree required. + Broad understanding ... of the life sciences industry and the evolving regulatory landscape, including the laws, regulations, and industry guidance that affect biopharmaceutical companies… more
- Insight Global (Danvers, MA)
- …candidate will have expertise in sterility assurance, microbiology, and regulatory compliance within a medical device environment. Key Responsibilities -Develop, ... and maintain sterility assurance programs for medical devices in compliance with FDA QSR, ISO 13485, and ISO 11135/11137 standards. -Provide technical leadership for… more
- Kelly Services (Boston, MA)
- …assurance within the biotechnology or pharmaceutical industry. + Strong knowledge of regulatory requirements and industry standards (eg, FDA , GMP). As part ... and procedures. + Collaborate with cross-functional teams to ensure compliance with regulatory standards. + Analyze quality data and trends to identify areas for… more
- Takeda Pharmaceuticals (Boston, MA)
- …metrics to identify trends and escalate emerging risks. + Support regulatory inspections and internal audits, ensuring high-quality deliverables. + Facilitate ... within the pharmaceutical industry. + Advanced understanding of global GxP regulations ( FDA , EMA, MHRA, PMDA, ICH). + Proven experience designing, implementing, or… more
- Hologic (Marlborough, MA)
- …concept through commercial launch. You will collaborate across engineering, regulatory , manufacturing, and quality teams-making high-level design decisions, setting ... teams. + Ensure solutions under development meet intended purpose and comply with regulatory and quality standards. + Serve as a technical expert and mentor, guiding… more
- Sanofi Group (Cambridge, MA)
- …competitive edge. + Collaborate with cross-functional teams to prepare for regulatory inspections and internal audits, ensuring compliance and addressing findings ... + 5+ years of experience in design controls and FDA / ISO 13485 / IEC 62304 compliant software.../ ISO 13485 / IEC 62304 compliant software development, regulatory submissions, and launch. + Having knowledge of EHR… more
- ThermoFisher Scientific (Bedford, MA)
- …quality efforts for PPA, the Director reports to the VP of Quality & Regulatory at BPG. They drive a customer-focused quality culture for a multi-site network. ... product lifecycle. + Coordinate compliance excellence by ensuring readiness for regulatory inspections (ISO 13485/9001, etc.), audits, and industry standards. +… more
- Sanofi Group (Cambridge, MA)
- …a manner that advances the company's strategy while addressing legal and regulatory risks and preserving and protecting the company's integrity and reputation. The ... highly valued. Ability to identify potential legal issues (focusing on promotional matters, regulatory issues and fraud and abuse) as well as proposed solutions to… more
- Boehringer Ingelheim (Boston, MA)
- …based. + Performs all Company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When ... verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week,… more
- Astellas Pharma (Westborough, MA)
- …knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial ... are met. + Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven… more