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Imbria Pharmaceuticals
Columbus, OH, 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 PharmaceuticalsProfessional Diversity Network
Columbus, OH, United States
AMERICAN MUNICIPAL POWER, INC. JOB DESCRIPTION This position has the ability to work out of Columbus, OH or remotely from AMP's footprint Position Title: Manager NERC Regulatory Affairs Reports To: Vice President Transmission & Regulatory Affairs FLSA Status: Exempt Basic Functions: 1. Increase AMP's presence and influence in the NERC stakeholde
Job Source: Professional Diversity NetworkFresenius Kabi USA, LLC
Columbus, OH, United States
Job Summary The Senior Director, Medical Affairs will provide global medical leadership for the R&D function of the Fresenius Kabi MedTech business, which includes medical devices and solutions associated with transfusion, cell therapies, and infusion technology. Participate in and guide risk management inputs for development projects, support defi
Job Source: Fresenius Kabi USA, LLCBeacon Hill Staffing Group
Columbus, OH, United States
Summary of Position The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking syste
Job Source: Beacon Hill Staffing GroupAmgen
New Albany
**HOW MIGHT YOU DEFY IMAGINATION?** You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology comp
Job Source: AmgenAmerican Electric Power
Columbus, OH, United States
**Job Posting End Date** 07-03-2024 Please note the job posting will close on the day before the posting end date **Job Summary** This position will be focused in the area of generation resource State regulatory filings, Integrated resource plan (IRP) filings, and other filings such as energy supply cost recovery and general cost recovery as needed
Job Source: American Electric PowerPrime AE Group, Inc
Columbus, OH, United States
PRIME AE Group, Inc. (www.primeeng.com), a multi-faceted A&E firm with 20 offices in 10 States and over 475 employees throughout the Midwest, Mid-Atlantic, Southeast, and Northeast, is seeking a Director of Structural Practice , for our Baltimore, Columbus, Akron or Pensacola offices. Company Overview and Vision: PRIME AE is a diverse community
Job Source: Prime AE Group, IncPrime AE Group
Columbus, OH, United States
PRIME AE Group, Inc. (www.primeeng.com), a multi-faceted A&E firm with 20 offices in 10 States and over 475 employees throughout the Midwest, Mid-Atlantic, Southeast, and Northeast, is seeking a Director of Structural Practice , for our Baltimore, Columbus, Akron or Pensacola offices. Company Overview and Vision: PRIME AE is a diverse community
Job Source: Prime AE GroupColumbus, OH, 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 Columbus, OH, United States
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