- Integra LifeSciences (Boston, MA)
- …Action/Preventive Actions (CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned. **DESIRED ... other cGMP regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality… more
- Philips (Cambridge, MA)
- …+ You've acquired a minimum of 10+ years combined experience working within FDA regulated medical device and clinical environments, with a focus on the development ... You have detailed knowledge of medical device regulations, requirements, and standards for FDA and EU especially for medium risk devices (Class II/Class IIA) focused… more
- Integra LifeSciences (Braintree, MA)
- …industry standards such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements. **Cross-Functional Collaboration:** + Work closely with sterility assurance and ... + Proficient with the MS Office Suite, and statistical software . + Must be able to work independently with...with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + This position could require up to 25%… more
- Integra LifeSciences (Braintree, MA)
- …and analyze process data. + Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits. + Demonstrate excellent ... Quality/Regulatory Compliance, or other regulated industry + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. +… more
- Integra LifeSciences (Braintree, MA)
- …or other product development studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned DESIRED MINIMUM ... other cGMP regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality… more
- Integra LifeSciences (Braintree, MA)
- …Process Validation, or other studies as deemed necessary. + Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal ... + Proficient with the MS Office Suite, and statistical software . + Must be able to work independently with...with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of TrackWise preferred. + Knowledge of… more
- Nanobiosym, Inc. (Cambridge, MA)
- …FPGAs (preferred but not required), ensuring low-level integration with embedded software . + Implement control systems in compact, single-board designs with tight ... functional testing. + Support regulatory and quality processes with a focus on FDA and ISO 13485 compliance. Minimum Qualifications: + Master's Degree in Electrical… more
- Olympus Corporation of the Americas (Westborough, MA)
- …analysis, etc. required for new and existing products. + Working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they ... in Geometric dimensioning and tolerance. + Must have working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they… more
- Spindrift (Newtonville, MA)
- …agreements, sustainability matters, website copy and marketing materials + Advise on FTC, FDA , and related regulations for food & beverage products + Mitigate risks ... strategies Technology & Data Privacy + Support legal review of software , tech platforms, consumer-facing digital tools (eg, e-commerce integrations), and website… more
- Eliassen Group (Marlborough, MA)
- …testing, ensuring that components meet design specifications. . Use CAD and other software tools to communicate and define designs. . Ensure all design and ... development activities adhere to regulatory requirements (eg, FDA , CE, MDR), and maintain detailed, accurate documentation throughout the product lifecycle.… more