- 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
- Integra LifeSciences (Braintree, MA)
- …or related field preferred. + 5+ years GMP/GLP laboratory experience in a medical device , pharmaceuticals, Quality/ Regulatory Compliance, or other regulated ... for, and participating in FDA audits, internal audits, and other regulatory agencies audits. + Demonstrate excellent organizational and time management skills.… more
- Integra LifeSciences (Braintree, MA)
- …relevant scientific discipline. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality/ Regulatory Compliance, or other cGMP ... US Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. **ESSENTIAL DUTIES AND… 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
- Takeda Pharmaceuticals (Boston, MA)
- …safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and ... the Company-wide patient safety expert for assigned pharmaceutical / biological / drug- device combined products, accountable for the safety strategy and major safety… more
- Medtronic (Boston, MA)
- …plays a critical role in ensuring the security of Medtronic Surgical Operating Unit medical device solutions. Reporting to the Director of Product Security, this ... and patients. _Make your impact by exploring a career with the world's leading Medical Device company, striving "to alleviate pain, restore health, and extend… more
- Fresenius Medical Center (Lawrence, MA)
- …remotely. **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non- medical software device engineering teams to ... product quality and minimize risk to users and patients as well as regulatory and corporate SOP compliance. . Reviews and approves design control deliverables along… more
- Astrix Technology (Boston, MA)
- …field-based medical affairs role within the pharmaceutical, biotechnology, or medical device industry. + Scientific Expertise: Deep understanding of ... Collaboration: Work closely with internal teams such as Clinical Development, Regulatory Affairs, and Commercial to provide medical insights that… more
- AbbVie (Waltham, MA)
- …medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's ... may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to… 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 and… more