- North Coast Seafoods (Boston, MA)
- …production staff and the Quality department for all Quality, Food Safety and Regulatory issues + Responsible for filling out assigned HACCP compliance documents + ... the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit +… more
- BioLife Plasma Services (Boston, MA)
- …and build your skills by contributing to financial, marketing, administrative, regulatory , quality, people, and facilities management. + **Contribute to Creating ... QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment **We Offer Comprehensive… more
- Medtronic (Newton, MA)
- …and debugging software that interfaces with hardware components. Experience with regulatory compliance and security protocols specific to medical software (eg, ... HIPAA, FDA regulations) is preferred but not required. The ideal candidate is a problem-solver at heart, adept at diagnosing and resolving complex problems while… 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
- 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 ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- Children's Hospital Boston (Boston, MA)
- …skill levels. + Ensures compliance with departmental quality initiatives, as well as regulatory and accreditation standards (Joint Commission, DPH, FDA , CMS). + ... Maintains professional skills and knowledge through educational programming, conference attendance, and leadership in professional organizations. Qualifications: + Minimum of a Bachelor's degree in Nutrition & Dietetics or a closely related field is required;… more
- Teleflex (Chelmsford, MA)
- …needed. Participate in vendor audits if necessary. Support the Back Room during regulatory and notified body audits. * Production & Process Controls - review, change ... Skills / Other Requirements** * Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements. * Computer skills, including proficiency with Microsoft Word, Excel,… more
- Rhythm Pharmaceuticals (Boston, MA)
- …document control perspective in Veeva QDocs, ensuring documents meet procedural and regulatory requirements. + Participate in validation efforts for new or updated ... systems, and learning management systems. + Strong working knowledge of relevant FDA , EU, ICH GMP regulations and guidelines with proficiency in interpreting and… more
- Rhythm Pharmaceuticals (Boston, MA)
- …1-2 years of Drug Safety and Pharmacovigilance experience. + Knowledge of FDA , ICH, EU Regulations and Requirements for Pharmacovigilance required. + Solid ... understanding of cross-functional drug development processes ( Regulatory , Clinical Operations, Data Management, and Biostatistics). + Demonstrable organizational and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …healthcare regulations and compliance standards relevant to cel therapies including, FDA guidelines, HIPAA requirements and other relevant IT system guidelines. + ... the cell therapies domain, including familiarity with the operations, clinical, and regulatory aspects. At Dana-Farber Cancer Institute, we work every day to create… more