- 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
- Norstella (Boston, MA)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... therapeutic research and industry trend analysis, including competitive positioning, regulatory changes, domain-specific insights, and opportunities + Drive innovation… more
- Medtronic (Boston, MA)
- …mitigation strategies in accordance with IEC 81001-5-1, ISO 14971, and FDA premarket cybersecurity guidance. + **Security Architecture & Design** - Collaborate ... through documentation, review participation, and active knowledge sharing. + ** Regulatory & Standards Compliance** - Ensure alignment with applicable standards… more
- Globus Medical, Inc. (Methuen, MA)
- …Ensure compliance with medical device standards (ISO 13485, IEC 60601, etc.) and regulatory guidelines. + Support design transfer from R&D to production under ISO ... 13485 and FDA guidelines. + **Innovation & Continuous Improvement** + Identify...and HIPAA compliance. + Knowledge of risk management and regulatory submissions + Excellent leadership, communication, ability to lead… more
- Philips (Cambridge, MA)
- …of 10+ years' experience in Design Quality Engineering /Risk management for FDA regulated Medical Device (21 CFR 820, ISO 13485/14971) New Product ... Quality Engineering teams. + You have extensive experience engaging with FDA investigators, other external regulators/auditors during inspections/audits and able to… more
- Integra LifeSciences (Braintree, MA)
- …Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. **Primary responsibilities are ... other product development studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned **Desire Minimum… more
- Integra LifeSciences (Braintree, 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
- Philips (Cambridge, MA)
- …device marketing is a bonus. + Your skills include a strong knowledge of key regulatory frameworks such as the FTC, FDA , CPSC, Lanham Act, state consumer ... engagements within the Personal Health sector. Skilled in navigating complex regulatory frameworks affecting consumer products, including medical devices, with a… 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …GxP compliance, Ethics & Compliance, and Pharmacovigilance, ensuring alignment with regulatory requirements and business objectives. This strategic leader will be ... engaging training ecosystem that enhances employee learning experiences and supports regulatory compliance. + Oversee the development and global deployment of… more