- Hologic (Marlborough, MA)
- …while supporting product development, manufacturing-related design changes, maintaining regulatory compliance, and enhancing manufacturability and cost efficiency. + ... Bachelor's Degree or 10+ years with a Master's Degree. + Expertise in FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Controls. Present the training process during audits and inspections, ensure regulatory commitments, manage the MABioOps training lab, advise on training ... etc. + Knowledge of cGMP's and applicable agency regulations (such as the FDA , EMA) to ensure inspection readiness of department **More about us:** At Takeda,… more
- Charles River Laboratories (Shrewsbury, MA)
- …with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling ... 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… more
- Hologic (Marlborough, MA)
- …systems including maintaining documentation and equipment history files. + Ensures regulatory compliance while supporting project milestones, goals, and schedules. + ... inclusive of disability and veterans._** **_\#LI-PR1_** **_Must follow all applicable FDA regulations and ISO requirements._** **_Hologic is an equal opportunity… more
- Cole-Parmer (Franklin, MA)
- …product line development in collaboration with Research & Development, Operations, Regulatory Affairs and Commercial teams. Implement appropriate programs to either ... markets preferably in diagnostics & molecular control markets. + Understanding of FDA and international regulated markets and how such regulations impact product… more
- Stantec (Boston, MA)
- …related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in ... in conformity with specifications, design intent and client/user and regulatory requirements. Working under the guidance of Director of commissioning/validation,… more
- Baystate Health (Springfield, MA)
- …ensure that the records are in compliance with safety codes set out by regulatory agencies such as the Joint Commission, Department of Public Health (DPH), HIPAA, ... Food and Drug Administration ( FDA ), National Fire Protection Association (NFPA), and National Electrical Code (NEC). **12)** Monitor workload and schedule activities… more
- Hologic (Marlborough, MA)
- …to have you on our team! **Knowledge:** + Strong understanding of FDA Quality System Regulations, particularly Design Control requirements. + In-depth knowledge of ... Detail-oriented and committed to maintaining the highest standards of quality and regulatory compliance. + Proactive and decisive, with the ability to independently… more
- ITW (Burlington, MA)
- …in process and final inspection of products and components used in NRC/ FDA regulated environment. **Primary Responsibilities** + Mechanical inspection + Tensile and ... and acceptance criteria + Assists with testing of product to demonstrate regulatory compliance + Assist with investigating problems and recommending / implementing… more
- Lundbeck (Boston, MA)
- …**Pharmaceutical Environment/Compliance** - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies ... and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. **REQUIRED EDUCATION, EXPERIENCE and SKILLS:** + Bachelor of Arts… more