- Takeda Pharmaceuticals (Boston, MA)
- …multiple studies (or across a compound) and related oversight activities ensuring quality and timeliness + Contributes to asset level strategies + Independently ... of CDISC standards, medical terminology, clinical trial methodologies, and FDA /ICH regulations + Leads and organizes programming activities for...new ways of working utilizing a wide variety of software (eg SAS, R, Python) + Proposes and embeds… more
- Abbott (Westford, MA)
- …devices involving both disposable and capital equipment that incorporates hardware and software + Understanding of FDA Guidances related to medical device ... stents, guide wires, balloon dilatation catheters, imaging catheters and hardware/ software , vessel preparation devices, vessel closure devices, and thrombectomy… more
- Charles River Laboratories (Worcester, MA)
- …with the clients. The scientist is expected to work independently to deliver high- quality non-GLP data in a fast-paced environment. The successful candidate in this ... and meet deadlines. Proficiency in the use of standard software including Microsoft(R) Excel, Word, PowerPoint, etc. and analytical...we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science… more
- Fujifilm (Boston, MA)
- …levels. + Minimum five (5) years of progressive experience as a Technical, Systems, Software or Quality Assurance Engineer in Medical IT and/or Imaging products. ... review calls with assigned staff for the purposeof evaluating and reporting project quality and timeliness. + Manages assigned projects as required to meet company… more
- Takeda Pharmaceuticals (Lexington, MA)
- …controls. + Collaborating with cross functional team members from mechanical, software , clinical, regulatory, and quality engineering disciplines. + Qualifying ... to design and development of product user interface including hardware, software , packaging, labeling, and instruction material to support safe and effective… more
- Bristol Myers Squibb (Devens, MA)
- …+ Proficient in application design and development + Strong understanding of software development methodologies and frameworks + Experience with cloud platforms and ... new tools and framework + Must have knowledge of Software Development Lifecycle (SDLC) and of computer systems validation...the BioPharma industry, such as GxP, HIPAA, GDPR, and FDA regulations. + Strong analytical and problem-solving skills, with… more
- Hologic (Marlborough, MA)
- …product owner. + Extensive commercial product development experience in medical devices and software development. + Familiarity with FDA 21 CFR 280 and IEC ... Owner, R&D** to lead the development of innovative medical devices and software solutions. This role offers the opportunity to work with cross-functional teams… more
- Charles River Laboratories (Wilmington, MA)
- …and determine which leads need immediate attention by Sales. **Process Optimization & Software Testing** + Participate in software and tool testing to drive ... areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Cytel (Boston, MA)
- …environment. The ideal candidate will contribute to the maintenance of critical software libraries, support graphics development in R, and help generate Tables, ... standards for regulatory submissions is essential. + Develop and maintain open-source software platforms with a focus on usability, stability, and scalability. +… more
- Dentsply Sirona (Waltham, MA)
- …+ Manufacture products using detailed instructions in full compliance with all FDA regulations and ISO & Quality requirements, in conjunction with ... portfolio of world class brands. Dentsply Sirona's products provide innovative, high- quality and effective solutions to advance patient care and deliver better… more
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