Regulatory Affairs Director (Medical Device)
Competitive Salary and Benefits
We have partnered with a Game Changing Medical Technology company who have developed a novel Medical Device which will save many lives.
This is a Class III Device and they require a Regulatory Leader, Snr Regulatory Manager / Regulatory Director to take them through PMA to ultimately achieve FDA approval and commercialisation. You will be working closely and interfacing with their unique Clinical trial program to compilate and lead the submission of required documentation.
This is a fantastic opportunity to step in as Director and work hands-on with an inspiring technology. The company will revolutionise this therapy area and are offering a great package with exciting share options.
- Coordinate and manage US, EU and Canadian regulatory activities, and ultimately global activities;
- Develop global RA strategies;
- Provide strategic regulatory guidance for NPD and clinical activities;
- Plan, review, and approve required documents from relevant departments for filing of required information to regulatory authorities; study protocols, investigator’s brochures, study reports and clinical evaluation reports;
- Write summary documentation such as labeling, literature search summaries, safety and efficacy summaries, and technical summaries;
- Manage communications and relationships with local authorities for specified projects;
- Develop procedures for regulatory submissions and compliance activities for investigational and commercial processes;
- Provide regulatory advice and guidance to product development for device changes;
- Initiate submissions-related projects teams and track and manage their deliverables for regulatory submissions;
- Provide regulatory review for patient and physician directed materials including training materials, trial documentation and advertising and promotion materials to ensure compliance with the device labeling and regulatory requirements;
- Maintain up-to-date knowledge of regulatory requirements; and
- Supervise, develop, and mentor regulatory personnel
· Strong track record with the FDA (Medical Device or Pharma)
· Ideally experienced with Class III Electro-mechanical device
· Ideally experience with PMA, (510(K) at the least)
· Eagerness to join and build a start-up company
· Willingness to be hands-on and take ownership of Regulatory Strategy and Documentation
If you are curious about this exciting opportunity as a Regulatory Affairs Director APPLY NOW and change your life today.
For more information about the role call Matthew for a confidential chat on 0203 8000 518 or email me on email@example.com.
Due to high demand, only successful applicants will be contacted. A consultant will reach you within 7 working days.
Projectus is the world leader in medical technology talent management.
Our sole mission is to connect medical technology companies with the best industry professionals across the globe. We place people across the full medical device spectrum including R&D, Regulatory, Engineering, Sales, Marketing, Clinical and Service.
For all our services visit www.projectusconsulting.com and discover more.