- Dana-Farber Cancer Institute (Boston, MA)
- …challenges, and adjustments. + Ensure compliance with all regulatory bodies (eg, FDA , AABB, FACT, NMDP) related to donor screening, collection, and processing. + ... Collaborate with multidisciplinary teams to optimize outcomes and support operational improvements efforts. + Maintain databases and systems related to donor information, ensuring accuracy and confidentiality. + Triage cases in a time sensitive manner, which… more
- Deloitte (Boston, MA)
- …familiarity with ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, ... NDA, BLA, MAA) + 1+ years experience leading, managing and delivering complex engagements with resources in multiple locations + Bachelor's Degree + Ability to travel up to 50% on average, based on the work you do and the clients and industries/sectors you… more
- Beth Israel Lahey Health (Burlington, MA)
- …of all aspects of clinical trials research complying with research SOPs, GCP, FDA and OHRP regulations; ensures adherence to regulations and educates study team ... members.** **Functions as a resource and educator for research study team members and other colleagues related to research conducted within the department.** **Acquires detailed knowledge of studies so to serve as a specialist; Grasps the scope and objectives… more
- Cole-Parmer (Franklin, MA)
- …+ Experience with European IVDD and IVDR compliance and regulations\ + Experience with FDA 21 CFR Part 820 regulations + Minimum of 10 years' experience related to ... quality assurance, lean manufacturing, regulatory compliance, and/or Six Sigma manufacturing Qualifications: + Holds Quality certifications in one or more of the following: ASQ/CQE, CMQ/OE, Six Sigma (Green or Black Belt) + Hands-on approach to troubleshoot… more
- Takeda Pharmaceuticals (Boston, MA)
- …Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA , EU, MHRA, PMDA and ICH. + Experience must include successful ... development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, deviation management, Serious Breaches, investigations and remediation activities on a global level. + Experience in managing complex… more
- Boehringer Ingelheim (Boston, MA)
- …+ Performs all company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and company policy and procedures. When ... violations are noted, they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community.… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications:** Baseline Qualifications: + Bachelor's Degree, Trade School Certification (Industry related), or Industry Experience Equivalent + One or more industry-specific certifications in relevant… more
- Teleflex (Chelmsford, MA)
- …Skills / Other Requirements** * Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements. * Computer skills, including proficiency with Microsoft Word, Excel, ... and PowerPoint is required. * Working knowledge and/or experience with SAP and AGILE is strongly preferred. * Good listening, verbal, and written communication skills * Excellent interpersonal skills with a demonstrated ability to work in a team environment. *… more
- Takeda Pharmaceuticals (Boston, MA)
- …in compliance with global regulations (eg, GxP, 21 CFR Part 11, ICH, EMA, FDA , PMDA) and Takeda's quality and risk management standards. + Work closely with ... architecture, engineering, quality, and data teams to ensure scalable and interoperable solutions across R&D. + Represent Development Technology product leadership in strategic governance forums, investment planning committees, and external regulatory or… more
- Tufts Medicine (Boston, MA)
- …and other outside agency requirements, such as the Joint Commission and FDA . 30. Participates in research activities. 31. Incorporates cultural and age appropriate ... care in all aspects of patient care and interactions with physicians, management, peers, and visitors in the OR, and anyone who will be greeted as a customer of the hospital. Has the skills and knowledge to provide care to the age groups of the population… more