Serves as the Regulatory Affairs lead on cross functional MDR project teams Ensures compliance with EU Medical Device Regulations (MDR) and EU guidance throughout the project. Actively participates in EU MDR project teams by attending meetings, collaborating with the project manager and cross functional team members, and communicating regulatory requirements and guidance

Government Relations Manager United States Virtual Req #463 Thursday, December 28, 2023 Want to help people learn the newest ways of working and getting things done? How you'll make a difference You will be responsible for planning, developing and executing a strong positive government relations and advocacy program for PMI. You will be fostering a community relationship

of the role Ardelyx is seeking a passionate individual who works with integrity and determination, to make a difference for patients. Reporting to the Vice President and Head of Global Patient Advocacy, the Director of Government Affairs will be responsible for leading and executing the Ardelyx government affairs strategy at the state and federal levels in close alignment

of the role Ardelyx is seeking a passionate individual who works with integrity and determination, to make a difference for patients. Reporting to the Vice President and Head of Global Patient Advocacy, the Director of Government Affairs will be responsible for leading and executing the Ardelyx government affairs strategy at the state and federal levels in close alignment

Create Change Orders to update regulatory documentation and Standard Operating Procedures as needed. Support the organization of regulatory files through IL's electronic Regulatory Affairs Database. Review labeling to comply with regulations and standards. Compile documentation to support new regulatory filings to health authorities (including FDA 510(k) submissions and I

Responsible for China NMPA and Japan PMDA registration and renewal activities for IL labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Tech

Responsible for domestic and/or international registration and renewal activities for Werfen labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintain

Additional Location(s) N/A Diversity Innovation Caring Global Collaboration Winning Spirit High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and train

Program Assistant Intern EPSIP Minimum Salary US MA Worcester Job Location 2 weeks ago (3/21/2024 1 02 PM) Requisition Number 2024 45739 # of Openings 1 Posted Date Day Shift Non Exempt Exempt/Non Exempt Status Non Union Position W00 Non Benefited Overview IMPORTANT Your application will not be considered without an essay Complete the online application and include a shor

Preparation and submission of clinical trial amendments to the IRB (i.e. central IRB, SMART IRB, MGB IRB) across multiple studies (amendments, consent forms, protocol summaries, subject materials). This may include other study documents received from industry sponsors throughout the course of the study, as well as smaller amendments to keep documents and processes up to d