- GRAIL (Annapolis, MD)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals. + Effective… more
- Oracle (Annapolis, MD)
- …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
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- ThermoFisher Scientific (Frederick, MD)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and ... requirements and desired marketing claims. + Author and/or review regulatory submissions, specifically device master files, ...count on, which includes: + A choice of national medical and dental plans, and a national vision plan,… more
- Fujifilm (Annapolis, MD)
- …**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
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …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
- Edwards Lifesciences (Annapolis, MD)
- …Bachelor's Degree in a related field with 5 years of related experience working in medical affairs , clinical affairs and/or clinical science **What else we ... internal/external working relationships + The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment… 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
- Guidehouse (Hanover, MD)
- …FDA/ICH guidelines and CDISC data standards + Experience in pharmaceutical industry regulatory affairs and/or quality assurance and/or quality control + Direct ... market research and technical evaluation panels. You'll also advise on clinical, regulatory , and manufacturing aspects of medical product development, ensuring… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …methods is required. Familiarity with Design Control requirements and knowledge of Medical Device Validations is preferred. **Education and Experience:** + ... Bachelor's degree. Typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs . Other fields can be considered with the appropriate experience… more
