- Parexel (Nashville, TN)
- …management experience is required. * Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. * Proven expertise ... Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are...for change control and post-approval requirements. * Collaborate with global functions to obtain documentation aligned with local requirements.… more
- Cardinal Health (Helena, MT)
- … experts who provide consulting services in a myriad of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects… more
- Abbott (Alameda, CA)
- …overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the ... Abbott is a global healthcare leader that helps people live more...working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site… more
- ThermoFisher Scientific (Washington, DC)
- …with a proven track record for successful negotiations with Health Authorities. Wider global regulatory knowledge is an advantage. + Ability to lead multiple ... meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission...in the future. **About the role:** The **Sr Director, Regulatory Strategy** will be responsible for advising clients on… more
- Philips (New Kensington, PA)
- …to manage special projects across a spectrum of product lines. + Monitor global regulatory landscapes and guide cross-functional teams on implementation of ... The Principal Regulatory Affairs Specialist will develop and execute the...materials, and claims substantiation evidence to maintain compliance with global requirements. + Identify areas for improvement for efficiency… more
- Kelly Services (Norcross, GA)
- …for medical devices, including in vitro diagnostics (IVDs). The role will support global regulatory compliance across US FDA, Health Canada, and EU Notified ... design teams for new products and significant product modifications. * Develop global regulatory plans, advising on product classification, registration paths,… more
- Pentax Medical (Montvale, NJ)
- …Medical's products for Endoscopes and Speech, Voice and Swallowing devices, meet global regulatory standards. This role will collaborate across teams, influence ... Medical provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Senior Regulatory ...the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an… more
- Terumo Neuro (Aliso Viejo, CA)
- …teams and partner with the cross functions on the team to ensure alignment of global regulatory strategy with the team objectives. + Identify regulatory ... Operating Procedures (SOP) and Work Instructions (WI). + Support training for global regulatory processes and system implementations. + Build team cohesiveness… more
- Amgen (Washington, DC)
- …license applications + Serve as functional area lead on product teams (eg, Global Regulatory Team, Evidence Generation Team, Global Safety Team, ... Label Working Group) + Provide functional area input for Global Regulatory Plan and team goals + Supervise the work of contract and freelance writers and mentor… more