Sr. Manager, Regulatory Affairs

Shifamed•Campbell, CA

20h•$175,000 - $200,000•Remote

About The Position

Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical, please visit www.supiramedical.com. ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology. Description: Responsible for US, EU and Japan Regulatory Affairs activities for a class III, breakthrough mechanical circulatory support system filed under PMA, EU Design Dossier(s) and Japanese Shonin. Devotes a significant portion of time to submission strategy, planning and writing. This is a full-time, remote position reporting to our office located in Los Gatos, CA as needed.

Requirements

B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience.
10+ years of US/EU Regulatory Affairs medical device industry experience.
Strong US and EU submission structure and writing skills.
Experience with at least 2 US PMA's through the complete cycle of IDE approval through PMA approval.
Experience with complex electromechanical medical devices involving both disposables and capital equipment (software-driven console).
Thorough knowledge of product development process and design control in relation to regulatory requirements.
Proficient knowledge of clinical trial strategy, study design and sponsor reporting requirements.
Overall understanding of global medical device regulations and direct experience with the following types of submissions associated with US, EU and Japan Class III Medical Devices.
Strong technical knowledge of class III medical device products.
Comprehensive understanding of relevant medical procedures, practices, terminology, and products.
Proficient knowledge of clinical trial strategy, study design and sponsor reporting requirements.
Thorough knowledge of product development process and design control.

Nice To Haves

US FDA cardiovascular medical device experience is strongly preferred.
Hands-on start-up experience is strongly preferred.

Responsibilities

Plans, structures and completes the writing of major regulatory submissions including US IDE, PMA, EU Design Dossiers and Japanese Shonin.
Directs and coordinates activities of Supira’s Regulatory Affairs consultants.
Establishes project priorities, allocates resources and balances workload for submission projects across Clinical, R&D, Quality and Regulatory Affairs.
Provides technical guidance to team during submission strategy, formulation, preparation and interaction with regulatory bodies.
Writes, reviews and edits submissions prepared by Supira personnel and RA consultants.
Acts as company representative, developing and maintaining positive relationships with medical device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow‑up of submissions under review.
Oversees preparation and submission of regulatory applications and maintenance of internal regulatory file documentation.
Oversees review of device labeling, including advertising materials, for compliance with applicable regulations; analyzes and recommends appropriate changes.
Establish and support a work environment of continuous improvement that supports the Supira Quality Policy, Quality System and the appropriate regulations for the area supported.