Email Alert for
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
The Mullings Group
Dallas, TX, United States
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
Job Source: The Mullings GroupThe Mullings Group
Dallas, TX, United States
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 de
Job Source: The Mullings GroupImbria Pharmaceuticals
Dallas, TX, United States
Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor
Job Source: Imbria PharmaceuticalsImbria Pharmaceuticals
Garland, TX, United States
Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor
Job Source: Imbria PharmaceuticalsImbria Pharmaceuticals
Garland, TX, United States
Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor
Job Source: Imbria PharmaceuticalsHunt Corporation
Dallas, TX, United States
Job Description Company Description: Hunt Energy Network (HEN), a subsidiary of Hunt Consolidated, provides world-class solutions for clean energy assets in ERCOT by developing and managing distributed energy resources, dispatched by HEN's proprietary TraDER platform. The mission of Hunt is to be a growth-oriented industry leader respected throug
Job Source: Hunt CorporationHunt Corporation
Dallas, TX, United States
Job Description Company Description: Hunt Energy Network (HEN), a subsidiary of Hunt Consolidated, provides world-class solutions for clean energy assets in ERCOT by developing and managing distributed energy resources, dispatched by HEN's proprietary TraDER platform. The mission of Hunt is to be a growth-oriented industry leader respected throug
Job Source: Hunt CorporationConfidential
Dallas, TX, United States
Executive Director, Regulatory Affairs About the Company Pioneering developer & manufacturer of innovative therapeutic medicines Industry Biotechnology Type Public Company Founded 1980 Employees 10,001+ Categories Biotechnology Biotechnology and Pharmaceuticals Biotech Health Care Pharmaceutical Pharmaceuticals Academic Research Manufacturing Genom
Job Source: ConfidentialGarland, TX, United States
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 clients 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
Email Alert for Hybrid : Remote / Director of Regulatory Affairs / Structural Heart PMA jobs in Garland, TX, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.