- Grifols Shared Services North America, Inc (Clayton, NC)
- …local market authorization holders and distributors. **Primary Responsibilities:** + Act as Regulatory Affairs authority for key product registrations with a ... more than 110 countries and regions. **Summary:** Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish… 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
- Edwards Lifesciences (Portland, OR)
- …up. **How you'll make an impact:** + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior Manager, ... Medical Affairs ) is responsible for providing scientific expertise throughout the...the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations. + Experience with FDA PMA… 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
- 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
- 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
- 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
- J&J Family of Companies (Horsham, PA)
- …partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (eg Biostats, GCO, Regulatory Affairs , QA and QC) to ... and regulatory standards. This position resides in the Medical Affairs Gastroenterology Therapeutic Area (TA) Team which is responsible for developing,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …upholding medical affairs framework standards. + Ensure adherence to US regulatory and industry standards including FDA promotional guidelines, PhRMA Code, ... + Up to date on emerging global and US regulatory , clinical , ethical and compliance trends and...USMA framework. + Act as key liaison between Medical Affairs , Regulatory , Legal, Compliance and Commercial teams… more
- Lundbeck (Deerfield, IL)
- …for a rare disease + Past responsibility for managing IIT process + FDA regulatory knowledge and direct exposure **TRAVEL:** + Willingness/ability to travel ... Provide medical perspectives to internal stakeholders (Commercial, Market Access, Regulatory , Clinical Development, Pharmacovigilance etc.) ensuring clinical… more