- Oracle (Boston, MA)
- …as Regulatory Affairs, Quality Compliance , Product Development, etc. in medical device industry or equivalent. Experience authoring submissions (510k, EU ... success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with… more
- Sanofi Group (Framingham, MA)
- …(GRA) Device team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro diagnostic (IVD) products ... strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our… more
- Sanofi Group (Cambridge, MA)
- …(GRA) Device team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro diagnostic (IVD) products ... strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our… more
- Takeda Pharmaceuticals (Lexington, MA)
- …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... Develop Device Clinical Development Strategy for Combination Products and Medical Devices + Develop comprehensive risk management strategies for devices and… more
- Globus Medical, Inc. (Methuen, MA)
- …in mechanical and electrical engineering principles, ensuring robust hardware solutions and compliance with medical device standards while driving innovation ... design. + Foster a culture of innovation, collaboration, accountability and compliance with medical device standards. Ensure timely delivery of milestones… more
- Globus Medical, Inc. (Methuen, MA)
- …of algorithm and software engineers. + Foster a culture of innovation, collaboration, and compliance with medical device standards. + Adhere to the letter ... in algorithms and software with leadership experience in regulated medical device environments and has a track...ISO 13485 and FDA guidelines. + **Regulatory & Quality Compliance ** + Ensure adherence to IEC 62304 ( medical… more
- J&J Family of Companies (Boston, MA)
- …moral character while professionally representing the company. + Comply with all corporate compliance , FDA, medical device , quality standards and ethics. + ... portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and… more
- Hologic (Marlborough, MA)
- …understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise in compliance issues and regulatory expectations. + ... and compliance . **Experience:** + Minimum 12+ years in the medical device industry. + Proven track record in quality system strategy, risk management,… more
- Sodexo (Hyannis, MA)
- …and medical device manufacturers to ensure medical device security while supporting regulatory compliance . This is a hands-on role requiring ... role is responsible for the technical execution of cybersecurity initiatives across medical device inventories in hospital and clinical environments. You will… more
- Integra LifeSciences (Braintree, MA)
- …High School Diploma or equivalent with 1+ years of experience in a medical device , pharmaceuticals, Quality/Regulatory Compliance , or other regulated ... specifications. + Maintains and records quality testing information as part of a DHR ( Device History Record). + Maintains work areas and equipment in a clean and… more