- Oracle (Dover, DE)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Bausch + Lomb (Dover, DE)
- …+ Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device , cosmetics or ... and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative...**We offer competitive salary & excellent benefits including:** + Medical , Dental, Eye Health, Disability and Life Insurance begins… more
- Fujifilm (Dover, DE)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Veterans Affairs, Veterans Health Administration (Wilmington, DE)
- …-Conducting prepurchase evaluations and address pre-implementation security issues to ensure medical device isolation architecture (MDIA) requirements are met, ... Management (HTM) department at a VA facility. Works in support of the medical equipment management program. In addition to duties at the full performance level,… more
- Otsuka America Pharmaceutical Inc. (Dover, DE)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Terumo Medical Corporation (Elkton, MD)
- …TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide ... Pharmaceutical Affairs Laws, the Canadian Quality System Regulation, and the Medical Device Directive. **Job Details/Responsibilities** + Manage a team of… more
- Hologic (Newark, DE)
- …leading major US and global clinical trials across multiple phases of medical device development. You'll ensure studies are executed on-time, on-budget, ... the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs , Program Management, Legal, Marketing, and Operations to… more
- Hologic (Newark, DE)
- …Are you passionate about driving innovation while ensuring compliance and quality in medical device development? At Hologic, we are seeking a **Lead Design ... devices, we want to hear from you! **Knowledge:** + In-depth understanding of medical device regulations and standards, including ISO 13485, ISO 14971, IEC… more
- Hologic (Newark, DE)
- …product lifecycle. As a subject matter expert, you will partner with R&D, Regulatory Affairs , and Manufacturing Engineering teams to embed quality and compliance ... Management), and EU MDR (Regulation 2017/745). + Advanced understanding of medical device standards, including usability, reliability, electrical safety, and… more
- BD (Becton, Dickinson and Company) (Hunt Valley, MD)
- …independently writing and executing process validation protocols. + Experience in a medical device or pharmaceutical manufacturing facility. + Moderate knowledge ... of possible** BD is one of the largest global medical technology companies in the world. Advancing the world...degree. + Typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs . + Other fields can be… more
- Hologic (Newark, DE)
- …with all related business groups including All Global Supply Chain Functions, Regulatory Affairs , and Quality Assurance, Supplier Quality Assurance, Engineering ... implementing and/or supporting Oracle EBS or equivalent Enterprise Solutions + Medical Device and/or regulated industry experience preferred. **Ready to… more