- Philips (Cambridge, MA)
- …the right fit if:** + You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field. Experience authoring ... recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and… more
- Trinity Health (Springfield, MA)
- …statements, rosters, etc. + Assists the Director with Joint Commission and other regulatory compliance , documentation, and other related regulatory duties. ... time **Shift:** Day Shift **Description:** Come join the Plant Operations team at Mercy Medical Center, part of Trinity Health Of New England! We are a member of… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …+ Minimum of 10 or more years in life science organizations, ideally in the medical device industry. Knowledge, Skills and Abilities + In-depth knowledge of ... compliance laws, regulations, and best practices, especially those relevant to the medical device industry. + Demonstrated experience as a strategic partner… more
- Philips (Cambridge, MA)
- …+ **Compiles** and **analyzes** clinical and safety data to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. ... 4, EU Medical Device Regulation). + **Author** and **maintain** clinical documentation, including...non-clinical evidence. + **Collaborates** with cross-functional teams to ensure regulatory compliance and to define medical… more
- Insight Global (Danvers, MA)
- …successful at this role the resource must have product labeling experience within the medical device field, managing CAPAs cradle to grave, prior EU MDR ... Privacy Policy: https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements 4+ years of medical device product labeling background SAP, ETQ or… more
- Kelly Services (Norwood, MA)
- …experience with:** + **Root cause analysis and CAPA processes** + ** Regulatory compliance (eg, medical device reporting, product risk assessments)** + ... oversee **continuous improvement initiatives** in line with QMS effectiveness. + Ensure compliance with **ISO 9001 and ISO 13485** standards and all applicable… more
- Bristol Myers Squibb (Devens, MA)
- …(Technical Services) within the pharmaceutical, biologics, cell therapy, or medical device industry. + MS/MBA/CPIM/ASQ/Lean Manufacturing/Procurement experience ... technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill BMS requirements to implement supplier changes.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Support the optimization of design control elements to comply with combination produce/ medical device regulations. Lead or assist in deviation, complaint and ... 13+ years or PhD and 7+ years preferably within the biopharmaceutical industry or medical device development and commercialization are desired. + Minimum of 7… more
- Amgen (Cambridge, MA)
- …sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key Responsibilities: + ... years of progressive experience as an engineer or scientist in relevant fields ( medical device development, manufacturing, etc.) + Proven track record of… more
- AbbVie (Waltham, MA)
- …to prepare submissions and partic + Makes key decisions on product quality, compliance and regulatory conformance issues for sterile, biological, liquid, solids, ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...letters of intent to ensure that the appropriate quality, compliance and regulatory aspects are met for… more