The Program's Mission
To create the next generation of industry professionals by providing a high intensity education for our Associate Consultants in the regulatory disciplines of Quality Management, Regulatory and Clinical Affairs in an immersive program format.
This is accomplished by:
- Providing an educational and mentoring head-start delivered by professionals who have a wide scope, depth, and breadth of industry experience.
- Providing the ability to see, interact, and assist at different stages of consulting for a wide range of organizations from start-ups to mature companies while gaining exposure to different leadership structures, teams, processes, challenges, and concerns.
The goal of the program is to fast-track new professionals in the medical device industry.
About the Program
The MEDIcept Leadership Immersion Program is a virtual team-based training and mentoring program. Participants may reside anywhere in the US. The program consists of small cohorts of classroom and on-the-job training rotations in the following format:
- Rotations of Immersive classroom training paired with real-world assignments in Quality, Clinical, and Regulatory Affairs.
- Followed by rotations of on-the-job training in each of the three disciplines, mentored by experienced industry professionals.
- At the end of the on-the-job rotations the Associate Consultant, Program Director, and Department Managers will work together to determine which discipline the associate consultant will move into. At that point the Department Manager of the selected discipline will become the Associate Consultants reporting manager for the duration of the program. At this point in the program, Associate Consultants will have gained a well-rounded overview in the areas of all three disciplines.
Upon the completion of two additional years of experience working at MEDIcept, Associate Consultants will have gained significant industry experience (approximately 5-7 years of traditional work experience) ahead of their peers.
What you will Learn in the Program
The Regulatory discipline will give exposure to:
- Introduction to Regulatory framework and strategy
- Drafting USFDA 510K / PMA submissions
The Quality discipline will provide exposure to:
- Regulations and framework
- The Quality Management System (QMS)
- Internal and External Audits
- Corrective Actions Preventive Actions (CAPA)
The Clinical discipline will provide exposure to:
- Scientific Concepts and Research Design
- Ethical and Participant Safety Considerations
- Data Management and Informatics
- Clinical Study Reports
- Post-Market Requirements and Clinical Follow-up
- Year 1 focuses on rotations in the areas of Regulatory Affairs, Clinical Affairs and Quality Management in the classroom with on-the-job training opportunities and mentorship in each of the three disciplines.
- Years 2-3 focus on deeper industry work experience interacting with a variety of small, medium to large company needs.
The MEDIcept Leadership Immersion Program is an investment in the future of industry professionals. The program requires a 3-year commitment from participants.
- If you have questions, please contact us at https://www.medicept.com/contact/
- Applications for this program typically open in late fall and close at the end of January.
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