Principal Regulatory Affairs Specialist

Shifamed•Los Gatos, CA

10d•Hybrid

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. 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. This is a full-time, hybrid position reporting to our office located in Los Gatos, CA.

Requirements

10+ years of medical device regulatory affairs experience in the US and EU.
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: IDE, PMA, EU Design Dossiers and Shonin.
Strong technical knowledge of class III medical device products.
Strong US and EU submission structure and writing skills.
Experience with at least 1-2 US PMAs through the complete cycle of IDE approval through PMA approval.
Experience with complex electromechanical medical devices involving both disposables and capital equipment (high risk 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.
Thorough knowledge of product development process and design control.
Excellent written and oral communication, technical writing and editing skills.
Strong organizational, leadership, interpersonal and influencing skills.

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.
Establishes project priorities, allocates resources and balances workload for submission projects across Clinical, R&D, Quality and Regulatory Affairs.
Provides technical guidance to Supira 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.