- Cognizant (Boston, MA)
- …processes Knowledge on ALM Test management tool Regulatory Knowledge: Strong understanding of FDA , EMA, GxP, and 21 CFR Part 11 requirements; experience with GAMP ... degree preferred. Certifications: (Optional) ISTQB, PMP, or relevant regulatory compliance certifications. **_Roles & Responsibilities_** Develop and implement comprehensive… more
- Merck (Boston, MA)
- …with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. **Primary ... submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently with regulatory agencies (… more
- Insight Global (Bedford, MA)
- …provides leadership at the project level, guiding quality and compliance in areas like development, cybersecurity, verification/validation, and maintenance. Key ... documentation throughout the product lifecycle. Advise teams on software compliance , including cybersecurity and privacy. Ensure product quality and documentation… more
- AbbVie (Worcester, MA)
- …all data used in GxP systems are connected, accurate, secure and in full compliance with AbbVie's global program and regulatory standards including FDA , EMA and ... role will lead and implement a site strategy in compliance with regulatory and AbbVie global expectations, champion key...integrity. + Ensure adherence to regulatory standards (e, g FDA , GxP etc.) + Manage remediation efforts, utilizing risk… more
- Integra LifeSciences (Braintree, MA)
- …quality systems, and a commitment to ensuring product safety and compliance . The ideal candidate should demonstrate proficient experience with quality management ... improvement **SUPERVISION RECEIVED** Under direct supervision of Sr. Quality Compliance Manager, Environmental Controls. **SUPERVISION EXERCISED** Indirect supervision of… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …quality engineering representative leading efforts to improve quality and compliance of components used in critical life-sustaining equipment. Essential Functions: ... with standards and regulations such as ISO13485, IS09001, and FDA 21 CFR Part 820. * Must be currently...M/F/D/V. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... teams such as: marketing, clinical development, medical affairs, public policy, and compliance to ensure that patient advocacy and medical society initiatives are… more
- Sumitomo Pharma (Boston, MA)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... protocols. + Oversee clinical trial execution, ensuring quality, patient safety, and compliance with GCP standards. + Develop and execute corporate clinical strategy… more
- Beth Israel Lahey Health (Boston, MA)
- …of patients for participation in multiple clinical trials, ensuring compliance with federal, state and institutional guidelines. Financial responsibilities including ... of adverse events and reports them according to the guidelines of the FDA , sponsoring drug accompany (if applicable) and the IRB. May interact with sponsors… more
- Medtronic (Boston, MA)
- …requirements. This high-impact role involves leading regulatory submissions, maintaining compliance , and driving collaboration across teams to support product ... processes, marketing materials, and clinical protocols to ensure regulatory compliance . + Monitor, evaluate, and enhance regulatory tracking and control… more