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.
Imbria Pharmaceuticals
Fort Worth, 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 PharmaceuticalsAlcon
Fort Worth, TX, United States
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, youll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our
Job Source: AlconAlcon
Fort Worth, TX, United States
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of ou
Job Source: AlconISTITUTO MARANGONI
Fort Worth, TX, United States
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of ou
Job Source: ISTITUTO MARANGONIRandstad US
Fort Worth
regulatory affairs specialist ii. + fort worth , texas (remote) + posted june 10, 2024 **job details** summary + $50 - $53.57 per hour + contract + high school + category life, physical, and social science occupations + reference48290 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you
Job Source: Randstad USTCWGlobal
Fort Worth
Job Description Job Description Regulatory Affairs Specialist (R&D/QA) Fort Worth, TX 76104 (*Local candidates- 3 days on site/2 days remote) $43-$45hr (Weekly pay + Benefits) 1yr contract (Excellent potential for extension or permanent) Full-time- M-F 8am-5pm Our client is a global team of innovators, leaders, creators, builders, and problem s
Job Source: TCWGlobalLegal Aid of NorthWest Texas
Fort Worth, TX, United States
POSITION ANNOUNCEMENT Position: Deputy Director of Litigation - (Full- Time Position) Closing Date : Immediately Available and Closed When Filled Location: Hybrid Remote - Fort Worth, TX (Administration) OVERVIEW: Legal Aid of NorthWest Texas (LANWT) seeks a Deputy Director of Litigation (D-DOL) to assist the Director of Litigation in overseeing
Job Source: Legal Aid of NorthWest TexasThe Ladders
Fort Worth, TX, United States
POSITION ANNOUNCEMENT Position: Deputy Director of Litigation - (Full- Time Position) Closing Date : Immediately Available and Closed When Filled Location: Hybrid Remote - Fort Worth, TX (Administration) OVERVIEW: Legal Aid of NorthWest Texas (LANWT) seeks a Deputy Director of Litigation (D-DOL) to assist the Director of Litigation in overse
Job Source: The LaddersFort Worth, 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 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
Email Alert for Hybrid : Remote / Director of Regulatory Affairs / Structural Heart PMA jobs in Fort Worth, 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.