- Integra LifeSciences (Boston, MA)
- …work experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other cGMP ... outcomes and set new standards of care. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** The Quality Control Technician II will be responsible for performing quality … more
- AbbVie (Waltham, MA)
- …may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...submissions and partic + Makes key decisions on product quality , compliance and regulatory conformance issues for… more
- Sanofi Group (Cambridge, MA)
- …delivery of Drug Device Combination Products and Medical Devices . Working within strict technical, scientific, and regulatory frameworks, you manage ... collaborating closely with cross-functional teams and interacting with Global Device / Quality Leadership Teams and other...Develops medical devices and drug device combination products following regulatory requirements (FDA,… more
- Abbott (Burlington, MA)
- …entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; ... complaints. Independently assesses the complaint to determine if a medical device report needs to be filed... Reporting) + Knowledge of the use, development, and regulatory environment of medical devices … more
- Hologic (Marlborough, MA)
- …for medical devices . + Advanced knowledge of electromechanical and IVD medical device standards and best practices. **Skills** + Proven ability to lead, ... and continuous improvement for our electromechanical in vitro diagnostics medical devices (IVDs). You'll also play a...years of quality engineering experience in the medical device industry, with a focus on… more
- Fresenius Medical Center (Lawrence, MA)
- …**PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non- medical software device engineering teams to ensure ... product development or on design changes to ensure product quality and minimize risk to users and patients as...minimize risk to users and patients as well as regulatory and corporate SOP compliance. . Reviews and approves… more
- Sanofi Group (Cambridge, MA)
- …was possible. Ready to get started? **Main responsibilities:** + Draft and prosecute high- quality patent applications for medical devices and drug delivery ... + Demonstrated proficiency to understand and draft patent applications for complex medical device technologies, including software-enabled devices and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of current global Good ... an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will...Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …IEC 62304 and ISO14791 requirements. + Proven track record of developing and gaining regulatory approval of medical devices and/or drug delivery systems. + ... optimization of design control elements to comply with combination produce/ medical device regulations. Lead or assist in...to meet device regulations. + Collaborate with Quality , Mfg, Regulatory , R&D, Clinical, Legal, Packaging,… more
- Teleflex (Mansfield, MA)
- …* 0-2 years of Quality Assurance experience working in the medical device manufacturing environment (a combination of education and experience will ... 2. Assists in ensuring the manufacturing processes comply with regulatory and quality system standards, including FDA,... quality and manufacturing related processes in a medical device environment, preferred. TRAVEL REQUIRED: 0… more