- Cardinal Health (Boston, MA)
- …You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team develops ... the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical requirements in… more
- Hologic (Marlborough, MA)
- …in internal and external audits, including facility, supplier, Notified Body, and FDA inspections. + Own preparation and presentation of materials for monthly ... preferred). **Experience:** + 5+ years of engineering experience in an FDA -regulated industry. + Demonstrated leadership in root cause analysis, complaint… more
- Hologic (Marlborough, MA)
- …implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you ... lasting impact on patient safety and innovation. **Knowledge** + Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO standards (eg, ISO… more
- Bristol Myers Squibb (Devens, MA)
- …delays and zero errors. + Provide clearance information to the designated brokers, FDA and other government agencies for entries. + Relay release information to ... to ensure that inbound shipments are not manipulated with or disbursed prior to FDA Release, as applicable. + Maintain and automate an Import Checklist to ensure… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ PhD, PharmD, MD, or equivalent strongly preferred. Proven track record working with FDA and regulatory strategy teams in the pharma industry in a policy capacity. ... + A minimum of 15 years of combined experience in the pharmaceutical industry, FDA law or policy, and/or scientific or regulatory policy. + Strong knowledge of… more
- Fresenius Medical Center (Lawrence, MA)
- …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 ... of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and validation or… more
- J&J Family of Companies (Danvers, MA)
- …and device safety requirements. + Maintain alignment with regulatory expectations (eg, FDA QSR/21 CFR Part 820, ISO 13485) and support regulatory submissions as ... devices (device hardware, electronics assembly, or related fields). + Working knowledge of FDA QSR/21 CFR Part 820 and ISO 13485. Experience supporting or leading… more
- IQVIA (Boston, MA)
- …significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Cardiovascular/Metabolic/Renal/Respiratory is ... given to candidates with recent previous health authority experience (current or ex- FDA medical reviewers, etc.)_** **Qualifications** + MD Degree required. + 15+… more
- Cardinal Health (Chicopee, MA)
- …to ensuring equipment reliability, reducing downtime, and maintaining compliance with FDA , ISO, and DEP standards and regulations. **Responsibilities:** + Perform ... equipment compliance and readiness. + Ensure all maintenance activities comply with GMP, FDA , and ISO 13485 standards. + Assist and maintain spare parts inventories… more
- Hologic (Marlborough, MA)
- …engineering, we encourage you to apply! **Knowledge:** + Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU ... year** with a PhD in a related field. + Experience in an FDA -regulated industry preferred. + Hands-on experience in root cause analysis, complaint investigations,… more