- GRAIL (Boston, MA)
- …regulatory, development, clinical affairs, quality, or program management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and ... Demonstrated knowledge of US and international regulatory frameworks and processes for medical device development and approvals. + Effective collaborator in… more
- J&J Family of Companies (Danvers, MA)
- …verification and validation plan and strategies while maintaining traceability. + Use Software as a Medical Device (SaMD) and Software in a Medical Device ... 3rd party audits, including follow-up on actions. + Drive compliance of QMS through authoring and updating Standard Operating...of 5 years of related work experience within the medical device industry on SaMD and SiMD… more
- Olympus Corporation of the Americas (Westborough, MA)
- …matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, including IEC ... development practices for continuous rapid product delivery while maintaining compliance and quality. + Provide project management oversight for...+ Minimum of 6 years of experience in a medical device setting. + Experience in the… more
- Hologic (Marlborough, MA)
- …Corrections and Removals), FDA Quality System Regulations, ISO 13485:2016, and EU Medical Device Regulation regarding field safety corrective actions. + ... with FDA Industry Guidance for Recalls and guidance on distinguishing recalls from medical device enhancements. + Understanding of MEDDEV 2.12/1 guidelines for… more
- Philips (Cambridge, MA)
- …in areas such as Medical /Clinical Affairs or Medical Safety/ Medical Affairs Risk Management in Meical Device industry. Prior hands-on bedside/clinical ... ** Medical Safety Manager, Complaints Handling** The Medical...matter expert in post-market surveillance activities to ensure regulatory compliance and patient safety. + Continuously evaluate and improve… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... enterprise quotes. + Understand the specialized requirements for quoting regulated medical software, hardware, and consulting; ensuring accurate compliance ,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Fellowship Trained Board Certification. + Minimum of 10-12 years of biotechnology/pharmaceutical/ medical device industry experience in medical affairs, ... live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care...your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential,… more
- Atrius Health (Boston, MA)
- …that lab and other test results are available in the electronic medical record (EMR). Delivers excellent customer service and strengthens the patient/clinician ... testing required for exams specific to the department. Ensures patients' electronic medical record (EMR) is updated with medical information, including recent… more
- TE Connectivity (Boston, MA)
- …technical and/or complex organizational leadership experience, and 5+ years of medical device sales and/or product management experience + Significant ... Senior Regional Sales Manager Medical OEM - Americas East & Latin America...to established budgets and manage team accordingly to ensure compliance + Manage team through effective system tools (ie,… more
- Astrix Technology (Boston, MA)
- …field-based medical affairs role within the pharmaceutical, biotechnology, or medical device industry. + Scientific Expertise: Deep understanding of ... teams such as Clinical Development, Regulatory Affairs, and Commercial to provide medical insights that inform strategic decisions. + Compliance and Reporting:… more