- 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 ... objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + This position could require up to 25% travel. **Preferred Skills:**… more
- Abbott (Burlington, MA)
- …improvement activities. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and Abbott policies, processes, ... or an equivalent combination of education and experience. + Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304),… more
- Nanobiosym, Inc. (Cambridge, MA)
- …steps. + Develop and implement validation protocols (IQ/OQ/PQ) that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with ... statistical process control + Recent experience with medical device development, in an FDA regulated (21 CFR 820) and/or ISO 13485 environment + Strong written and… more
- Nanobiosym, Inc. (Cambridge, MA)
- …Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission + Manage and contribute to regulatory documents + Project ... managerial and leadership expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience +… more
- AbbVie (Waltham, MA)
- …long-term R&D and innovation strategies. Focus is on pipeline development and the FDA and IRA considerations when assessing strategic approaches. This is not a role ... focused on FDA advertising and promotional considerations. + Educates other AbbVie legal departments and business stakeholders on emerging laws, regulations and… more
- Abbott (Westford, MA)
- …and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA , GMP, and all other applicable agency regulations. + Ensure a safe work ... environment. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Charles River Laboratories (Cambridge, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Fresenius Medical Center (Boston, MA)
- …benchmarking. + Experience in mining a variety of online resources, such as EDGAR, FDA device and drug databases, NCBI and PitchBook. + Advanced skills with MS ... Office (Excel, Word, PowerPoint). + Superior written and oral communication skills. + A team player, with an insatiable curiosity, the ability to scale steep learning curves on a short clock, a ˜can do' attitude, the self-confidence to work independently, and… more
- Sanofi Group (Framingham, MA)
- …industry techniques and develop cell culture subject matter expertise in an FDA -regulated setting. We are an innovative global healthcare company with one purpose: ... to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready… more
- Charles River Laboratories (Wilmington, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more