- Stryker (Columbia City, IN)
- …with medical devices. + A minimum of 7 years of Medical Device Regulatory Affairs experience required. **Preferred** + Master's degree in Regulatory ... and technical guidance to product development teams. + Evaluate clinical and manufacturing changes for regulatory filing...+ Evaluate clinical and manufacturing changes for regulatory filing requirements. + Review and assess regulatory… more
- BD (Becton, Dickinson and Company) (Louisville, CO)
- **Job Description Summary** The Regulatory Affairs Specialist II is responsible for implementation of strategies including domestic and international submissions ... Must be able to maintain confidentiality in dealing with regulatory and clinical documentation **EDUCATION and/or EXPERIENCE**...with software and capital systems is a plus. + Regulatory Affairs Certification (RAC) desired At… more
- Stryker (Las Vegas, NV)
- The **Senior Director, Regulatory Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and ... desired **Knowledge / Competencies:** + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA , and International requirements +… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …systems; or Combination of education and experience determined to be equivalent + Regulatory Affairs Certification (RAC) desired + Knowledge of the US and ... European medical device regulations preferred + Maintain confidentiality in dealing with regulatory and clinical documentation + Excellent written and verbal… more
- Veterans Affairs, Veterans Health Administration (Seattle, WA)
- …a critical role in planning, developing, and influencing implementation of quality, regulatory and medical device design projects that support the success of X_Labs. ... designers, as well as manufacturing staff to design medical devices. Comprehends clinical approach, clinical datasets (DICOM), patient anatomy, and potential… more
- Medtronic (Mounds View, MN)
- …as well as other cross-functional stakeholders (eg, Research and Development, Corporate Biostats, Regulatory Affairs , Clinical IT, and others). The Principal ... complex clinical studies/projects in compliance with applicable clinical and regulatory standards and in alignment...including CER and PMCF reports, with specific understanding of FDA , EU CE Mark, MDD, and MDR regulations. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead will ... GRA A&P SME for assigned products and projects. + Regulatory advisor as the "R" in the core Medical,...management input or alignment. + Strategic business partner from clinical trial development through the marketing maintenance phase of… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …of all products. Provides clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world as needed. + ... functioning in terms of leadership, compliance and productivity. The Director, Medical Affairs , will drive the clinical development and evidence generation plans… more
- HRPivot (Tucson, AZ)
- …and clinical studies. + Partner with Regulatory Affairs and Clinical teams to support FDA PMA submissions and interactions with regulatory ... development of a highly advanced Class III medical devices through concept, preclinical, and clinical stages to FDA PMA approval. The ideal candidate has deep… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …Processes; Clinical Development Tools and Processes; Medical Affairs Guidelines; Regulatory Guidelines; Pharmacovigilance Guidelines; Domains across ... pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US ( FDA regulatory... Affairs plans and Dr. Reddy's Canada Medical Affairs plans in consideration of best clinical … more