Mene Research Regulatory Group efficiently manages and successfully executes all aspects of global start-up according to Sponsor specifications.
- Perform quality checks on submission documents and site essential documents;
- Interact with Authorities, CEC, EC, sites, and international associates;
- Prepare and approve and adopt to local requirements of informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Present during bid defenses, general capabilities meetings, and audits
- Ensure that the sections are complete, well written, and meet all relevant requirements. Develop excellent relationships with internal functional groups; contract manufacturing organizations, and partners.
- Facilitate device clinical trial and commercial application/registration by providing timely, relevant, targeted regulatory intelligence
- Develop and continuously maintain the regulatory knowledge management tool