- Biomat USA, Inc. (Worcester, MA)
- …activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a ... all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration… more
- Medtronic (Boston, MA)
- …Ensure all software verification activities adhere to relevant medical device regulations (eg, FDA 21 CFR Part 820, ISO 13485, IEC 62304) and internal quality ... cross-functionally with software development, systems engineering, quality assurance, and regulatory affairs teams to ensure seamless integration and verification of… more
- Integra LifeSciences (Braintree, MA)
- …implement process-level efficiencies + Drive continuous improvement + Maintains all ISO/ FDA standard operating procedures, work instructions, and forms. + Maintains ... storage. + Minimum of 1-2 years' experience in a Quality Systems I Regulatory Compliance environment with a working knowledge preferably in the medical device,… more
- J&J Family of Companies (Danvers, MA)
- …with cross-functional teams to ensure effective integration of design, clinical, regulatory , and marketing activities throughout the product development lifecycle. + ... the successful launch of new products, ensuring compliance with all regulatory requirements and industry standards. + Drive adoption of next-generation capabilities… more
- Pfizer (Cambridge, MA)
- …contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports ... Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA , EMA, and global regulations. + Strong scientific writing skills and… more
- Astrix Technology (Boston, MA)
- …including RNA, genomic, proteomic, and imaging-based markers. + Contribute to global regulatory submissions (eg, INDs, CTAs) and provide medical input in alignment ... with FDA , EMA, and ICH guidelines. + Collaborate with cross-functional...Collaborate with cross-functional teams, including preclinical, clinical operations, and regulatory affairs, to integrate and execute clinical strategy. +… more
- Sanofi Group (Cambridge, MA)
- …strategy, and the network of collaborators from preclinical research to operational, regulatory and commercial functions. Success in this role requires the ability ... The GPH will be delegated such responsibilities as interaction with regulatory /health authorities, approval of protocols, informed consent documents, clinical study… more
- Takeda Pharmaceuticals (Boston, MA)
- …processes and training and ensure alignment with global processes and regulatory requirements and expectations. + Drive the implementation and change management ... enable execution of CPMQ activities, ensuring alignment with global processes and regulatory requirements. + Create and deliver training solutions to support the… more
- Cardinal Health (Boston, MA)
- …to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company ... (GPOs, IDNs, hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory /compliance and contract manufacturing. **_Responsibilities_** + Demonstrate strong business… more
- Sanofi Group (Cambridge, MA)
- …strategic business support to maintain Sanofi's commitment to ethical practices and regulatory compliance. We are an innovative global healthcare company with one ... monitoring program across multiple Business Units to ensure compliance with regulatory requirements, internal policies, and product messaging + Maintain robust… more