Regulatory Management

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