Director of Global Regulatory Affairs
Class III : Structural Heart : PMA
Santa Clara : Hybrid Remote
Full Time : Direct Hire
Our client is developing the first transcatheter septal occluder with a metal-free frame, as the new standard of care for atrial septal defects.
Delivered through a 12F sheath and over a standard guidewire, the low-profile device features bioresorbable filaments connecting two polyester fabric patches, which contain radiopaque markers.
The device is fully deployed with the guidewire in place, providing the opportunity to reattach and reposition when necessary.
Currently seeking a new Global Director of Regulatory Affairs to help spearhead our client's 1st generation PMA submission as well as future supplements and OUS international registries for global commercialization.
The new Global Regulatory Affairs Director is a critical hire to this organization leading PMA regulatory negotiations as the FDA point person as well as guiding clinical affairs, quality management, R&D, and all company team leaders toward successful pre-market approval.
Position Responsibilities :
- Responsible for adherence to established company Quality System procedures and applicable work instructions
- In collaboration with the VP of Clinical and Regulatory Affairs, sets the vision, philosophy and objectives for Regulatory initiatives in the company;
builds company alignment on Regulatory objectives; and effectively implements the program.
Shares in responsibility to represent the company on worldwide communication with regulators globally, including FDA, European Notified Bodies and Competent Authorities and other regulators as needed.
When needed, serves as company spokesperson for Regulatory at community and industry affairs.
- Develops the regulatory strategy and pathway for market approval and new product introduction worldwide.
- Oversees and coordinates the execution of operational regulatory activities such as local country registrations.
- Carries out regulatory intelligence activities and keeps abreast of regulatory changes that may impact the company. Manages regulatory change implementation.
Qualifications / Experience :
- 10+ years of experience working on Class III medical devices regulatory projects
- Proven ability to work effectively with cross-functional stakeholders in a complex and changing global environment
- Demonstrated expertise with cardiovascular applications
- Experience in an innovative medtech startup mandatory
- Track record of managing multiple competing priorities
- Exceptional written and verbal skills
- Self-driven and highly collaborative with high personal accountability
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Eligibilities & qualifications....