- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The **Global Quality Audit Manager ** is responsible for planning, executing, and reporting on global audits to ensure **Good Clinical Practice (GCP) compliance** ... a key member of the Global Quality Management team, the Audit Manager will collaborate with cross-functional stakeholders to identify risks, drive continuous… more
- J&J Family of Companies (Danvers, MA)
- …Description:** We are searching for the best talent for an Engineering Project Manager - Console. Fueled by innovation at the intersection of biology and technology, ... for saving lives. We are seeking a highly motivated and experienced Project Manager to lead the ongoing sustainability of the Impella AIC system. This critical… more
- Integra LifeSciences (Braintree, MA)
- …and set new standards of care. **SUMMARY DESCRIPTION** The Associate Manager , Quality Compliance supports the development, maintenance, and continuous improvement of ... in ensuring ongoing regulatory compliance across site operations. The Associate Manager will also support external audit readiness and execution, including… more
- Hologic (Marlborough, MA)
- Sr Manager , Quality Assurance Newark, DE, United States Marlborough, MA, United States Are you a strategic leader with a passion for driving compliance, quality ... regulated environment? At Hologic, we are seeking a **Senior Manager , Quality Assurance** to lead the development, implementation, and...Systems (QMS) and electronic documentation systems. + Expertise in FDA 21 CFR Part 820, ISO 13485:2016, EU MDR… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Manager , Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across ... recordkeeping, and reporting. + Working knowledge and understanding of FDA /ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and… 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 ... Experience in medical software regulation such as (ISO 13485, FDA 21 CFR Part 820). **Physical Job Requirements** The...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Globus Medical, Inc. (Methuen, MA)
- …We are seeking an experienced Systems Engineering and Hardware Systems Manager to lead a multidisciplinary team driving innovation in next-generation surgical ... transfer from R&D to production under ISO 13485 and FDA guidelines. + **Innovation & Continuous Improvement** + Identify...and real-time control systems are preferred + Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA… more
- Takeda Pharmaceuticals (Lexington, MA)
- …work is done in compliance with IEC 62366 & regulatory body (example, FDA ) expectations. Drive HF/UX initiatives in early stage, development, and LCM projects, ... ensuring strategic and rigorous execution and timely delivery. **ACCOUNTABILITIES:** Senior Manager is responsible for Human Centered Design of Medical Devices and… more
- ThermoFisher Scientific (Waltham, MA)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a crucial role in interpreting and disseminating ... specifically device master files, regulatory support files, and meeting requests to FDA and other regulatory bodies. + Provide regulatory direction to product… more
- Globus Medical, Inc. (Methuen, MA)
- …as possible. **Position Summary:** We are seeking an experienced and innovative Manager to lead a multidisciplinary team of algorithm engineers and software ... transfer from R&D to production under ISO 13485 and FDA guidelines. + **Regulatory & Quality Compliance** + Ensure...Medical Image Processing is a plus + Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA… more