![The Mullings Group](https://media.trabajo.org/img/noimg.jpg)
Hybrid : Remote / Director of Regulatory Affairs / Structural Heart PMA
2 weeks ago
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
#J-18808-Ljbffr
-
Senior Director/Director of Regulatory Affairs
4 weeks ago
Washington, United States Tempus Full timePassionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...
-
Regulatory Affairs Specialist Us
4 weeks ago
Washington, United States Clinglobal Group Full time**Regulatory Affairs Specialist - United States of America** Clinglobal is an Animal Health Contract Research Organisation and supports our global operations in various countries. We are currently looking for a** Regulatory Affairs Specialist** based in the United States of America to join our growing Regulatory Affairs team at **Clinglobal**. This...
-
Regulatory Affairs Senior Director
1 month ago
Washington, Washington, D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Regulatory Affairs Senior Director
4 weeks ago
Washington, Washington, D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Regulatory Affairs Senior Director
2 weeks ago
Washington, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Regulatory Affairs Senior Director
2 weeks ago
Washington, Washington, D.C., United States BioSpace Full timeJob DetailsHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better...
-
Director, Federal Government Affairs
3 weeks ago
Washington, United States Consumer Healthcare Products Association Full timeJob Summary: **Responsibilities**: - Develop and implement regulatory strategies to ensure compliance with industry standards and regulations - Monitor and interpret regulatory developments and communicate potential impact to stakeholders - Lead interactions with regulatory agencies, including submissions, meetings, and negotiations - Collaborate with...
-
Executive Branch
2 weeks ago
Washington, United States The Williams Companies Inc Full timeThe Executive Branch & Federal Regulatory Affairs Director is responsible for translating our position and business objectives into government affairs strategies and actions. This role will serve as a recognized leader internally and externally withi Regulatory Affairs, Director, Regulatory, Executive, Benefits, Total Rewards, Business Services
-
Counsel/Senior Counsel, Regulatory Affairs
2 weeks ago
Washington, United States MFA Full timePosition Title: Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience)Location: Washington, DC (Hybrid)Reports to: Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory AffairsCompany Background: MFA, based in Washington, DC, New York, Brussels, and London, represents...
-
Counsel/Senior Counsel, Regulatory Affairs
2 weeks ago
Washington, United States MFA Full timePosition Title: Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience)Location: Washington, DC (Hybrid)Reports to: Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory AffairsCompany Background: MFA, based in Washington, DC, New York, Brussels, and London, represents...
-
Regulatory Affairs Managers
3 weeks ago
Washington, United States Course Advisor Full timeJob Description & Duties Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.A Day in the Life of a Regulatory Affairs Manager Develop and maintain standard operating procedures or local working practices.Participate in the development or implementation of clinical...
-
State Regulatory Affairs Internship
2 months ago
Washington, United States Edison Electric Institute Full time**Overview** The Edison Electric Institute (EEI) is seeking a talented and committed intern to join the State Regulatory Affairs team this summer. This role provides the opportunity to learn about and support the portfolio of projects and programs within our state regulatory affairs team. The dates of this internship are mid-May through mid-August and...
-
State Regulatory Affairs Internship
4 weeks ago
Washington, United States Edison Electric Institute Full time**Overview** The Edison Electric Institute (EEI) is seeking a talented and committed intern to join the State Regulatory Affairs team this summer. This role provides the opportunity to learn about and support the portfolio of projects and programs within our state regulatory affairs team. The dates of this internship are mid-May through mid-August and...
-
Regulatory Affairs Managers
4 weeks ago
Washington, United States Grad Degree Full timeCareer Description Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. Regulatory Affairs Manager Responsibilities Direct the preparation and submission of regulatory agency applications, reports, or correspondence. Train staff in regulatory policies or...
-
Regulatory Affairs Managers
2 weeks ago
Washington, Utah, United States Course Advisor Full timeRegulatory Affairs Manager Job Description & Duties: Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. A Day in the Life of a Regulatory Affairs Manager: Develop and maintain standard operating procedures or local working practices. Participate in the development...
-
Regulatory Affairs Senior Director
1 month ago
Washington, United States Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you're part of something bigger, it's because you are. 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 companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better...
-
Regulatory Affairs Senior Director
4 weeks ago
Washington, United States Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you're part of something bigger, it's because you are. 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 companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better...
-
Regulatory Affairs Managers
4 weeks ago
Washington, United States Courseadvisor Full timeJob Description & Duties Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures. A Day in the Life of a Regulatory Affairs Manager Develop and maintain standard operating procedures or local working practices. Participate in the development or implementation of clinical...
-
State Regulatory Affairs Internship
3 weeks ago
Washington, United States Edison Electric Institute Full timeOverview The Edison Electric Institute (EEI) is seeking a talented and committed intern to join the State Regulatory Affairs team this summer. This role provides the opportunity to learn about and support the portfolio of projects and programs within our state regulatory affairs team. The dates of this internship are mid-May through mid-August and requires...
-
Regulatory Affairs Senior Director
1 month ago
Washington, United States BioSpace Full timeJob DetailsHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better...