- Beth Israel Lahey Health (Burlington, MA)
- …general research duties. Implements study protocols in accordance to regulatory and institutional requirements. Works closely with principal investigators, research ... medical conditions and diagnoses. **Job Description:** 1) Possesses ongoing knowledge of FDA , OHRP and GCP regulations: + Ensures adherence to regulations. +… more
- Integra LifeSciences (Boston, MA)
- …US Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. + Responsible for performing ... Action/Preventive Actions (CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned. **DESIRED… more
- Sanofi Group (Cambridge, MA)
- …medical science, clinical trials, marketing strategies, and key publications. + ** Regulatory and Compliance Oversight** : Oversee the medical review and approval ... of regulatory documents, ensuring adherence to company standards and government/industry...skills. + Strong understanding of clinical trials processes and FDA approval processes, including accelerated approval, and FDA… more
- Fresenius Medical Center (Lawrence, MA)
- …product quality and minimize risk to users and patients as well as regulatory and corporate SOP compliance. . Reviews and approves design control deliverables along ... and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning and implementation of risk… more
- Integra LifeSciences (Braintree, MA)
- …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of ... activities. The role works with Product Development, Project Management, Regulatory , Marketing and Medical Affairs. **ESSENTIAL DUTIES AND RESPONSIBILITIES** +… more
- Integra LifeSciences (Braintree, MA)
- …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + This position ... industry standards such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements. **Cross-Functional Collaboration:** + Work closely with sterility assurance and… more
- AbbVie (Waltham, MA)
- …R&D organization in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients. ... leaders within the R&D and corporate strategy organizations on legal and regulatory issues that impact pipeline development, government agency engagement and product… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** Act as the primary… more
- Takeda Pharmaceuticals (Boston, MA)
- …and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's ... and a brighter future. **How will you contribute:** + Ensure compliance to Regulatory Intelligence Procedures by executing the regulatory intelligence process in… more
- Sanofi Group (Cambridge, MA)
- …leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, ... Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to… more