- United Therapeutics (Boston, MA)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of… more
- Philips (Cambridge, MA)
- …+ **Leads** the medical writing team in planning and delivering high- quality , compliant documents through effective resources, budget, and timeline management. + ... + You've acquired a minimum of 10+ years combined experience working within FDA regulated medical device and clinical environments, with a focus on the development… more
- Medtronic (Boston, MA)
- …the software verification lifecycle, ensuring efficient and effective delivery of high- quality software. + Drive the adoption and continuous improvement of software ... + Ensure all software verification activities adhere to relevant medical device regulations (eg, FDA 21 CFR Part 820, ISO 13485, IEC 62304) and internal quality … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and guidelines. - Confirms submission documents are accurate, compliant, and high- quality to allow for smooth and expeditious approvals from regulatory authorities. ... with GRA department to execute departmental initiatives to improve overall efficiency, quality , and/or output. - Assess and develop innovative ideas to move GRA… more
- Nanobiosym, Inc. (Cambridge, MA)
- …Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission + Manage and contribute to regulatory documents + Project ... issues + Maintain compliant laboratory documents and procedures + Pro-actively improve efficiency, quality and effectiveness of R & D efforts QUALIFICATIONS + PhD in… more
- Charles River Laboratories (Wilmington, MA)
- …service and compliance documentation as required by company policy, cGMP and FDA . * Responsible for resolving client testing laboratory instrument service issues. ... industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy...development of ~85% of the drugs approved by the FDA in 2019. Equal Employment Opportunity Charles River Laboratories… more
- Cardinal Health (Boston, MA)
- …to update manufacturer knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct secondary research (eg, ... manufacturers and products. + **Executive presentations:** Consolidate information into high- quality presentations or memos with meticulous attention to detail.… more
- System One (Devens, MA)
- …Perform safe, timely, and cost-effective production of pharmaceutical products that meet quality and regulatory standards. + Operate in an aseptic environment while ... Accurately complete batch records and documentation in compliance with FDA and cGMP guidelines. + Ensure all production and...get work done more efficiently and economically, without compromising quality . System One not only serves as a valued… more
- Rhythm Pharmaceuticals (Boston, MA)
- …of eCTD submission-ready documents, coordinating across functions, and ensuring quality , accuracy, and adherence to regulatory guidelines. Additionally, the ... + Assist in the development of Standard Operating Procedures (SOPs) quality assurance, and records management practices related to regulatory operations activities… more
- Integra LifeSciences (Braintree, MA)
- …preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred. + ... implement process-level efficiencies + Drive continuous improvement + Maintains all ISO/ FDA standard operating procedures, work instructions, and forms. + Maintains… more