- 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
- Bayer (Annapolis, MD)
- …As the Director of Regulatory Affairs , you will represent our medical device regulatory team within the Molecular Imaging platform. This pivotal ... are required + Direct professional experience in Regulatory Affairs within the medical device industry, with significant experience involving medical… more
- Bausch + Lomb (Annapolis, MD)
- …+ 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 (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
- Sanofi Group (Washington, DC)
- …strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team...teams. + Contribute to and execute innovative and sustainable medical device regulatory strategies covering… more
- FleishmanHillard (Washington, DC)
- …intersection of healthcare and public affairs in service to pharmaceutical and medical device companies, as well as third party organizations to include ... Additional desired areas of expertise include issues advocacy and public affairs campaigns, strong writing skills, and stakeholder engagement with policy and… 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
- Amgen (Washington, DC)
- …will lead the end-to-end digital strategy, delivery, and operational excellence of Global Regulatory Affairs and Safety (GRAAS) systems. This role will provide ... & Program Ownership** + Lead the global digital strategy and roadmap for regulatory operations across domains such as RIM, CMC/ device , labeling, publishing,… more
- Philips (Washington, DC)
- …a minimum of 10+ years' experience in FDA Regulations, Global Regulatory Affairs , Policies and Standards within the Medical Device /Technology industry or ... The Regulatory Science & Policy Director is responsible for...Director is responsible for guiding the analysis of global regulatory requirements, policies and industry standards to identify their… 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
- 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
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …your best self. Become a **maker of possible** with us. **Position Title: Medical Writer** Department: Medical Affairs , Diagnostic Solutions Reports to: ... + Lead collaboration with internal and external authors plus Regulatory and Legal reviewers throughout the entire manuscript development... medical writing, preferably at a diagnostic or medical device company. + Master's degree in… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …cross-functional teams, including software development, product management, quality assurance, and regulatory affairs , to ensure alignment and a shared ... software test or QA team + Proven experience in a regulated industry, preferably medical device , in-vitro diagnostics (IVD), or a related healthcare field +… 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
- Exelon (Baltimore, MD)
- …gas operations, customer service, transmission and substation, distribution system operations, regulatory and external affairs ). + Advanced proficiency in ... and back-office remediation efforts, while also leading long-term planning for device management beyond 2030.** **Key skills required include project management… more