Principal Regulatory Affairs Specialist

Supira Medical, Inc.; Los Gatos (CA); Hybrid; USD 150,000 - 180,000; Full time

Benefits offered by this job

Equity

Benefits

Job summary

Supira Medical, Inc. is seeking a Regulatory Affairs leader to manage US, EU and Japan submissions for a class III, Breakthrough mechanical circulatory support system. The role involves strategy, writing, and coordination with internal teams and external consultants from our Los Gatos, CA office.

You will guide IDE, PMA, EU Design Dossiers, and Shonin filings, ensuring regulatory compliance across regions. Strong communication and project management skills are essential for success in this

Qualifications

• 8+ years of medical device regulatory affairs experience in the US and EU.
• Experience with IDE, PMA, EU Design Dossiers and Shonin.
• US FDA cardiovascular medical device experience strongly preferred.
• Hands-on startup experience is strongly preferred.

Responsibilities

• Plans, structures and completes major regulatory submissions (IDE, PMA, EU Design Dossiers, Shonin).
• Sets project priorities and allocates resources across Clinical, R&D, Quality and Regulatory Affairs.
• Provides guidance to Supira team during submission strategy and regulatory pathway development.
• Writes, reviews and edits submissions prepared by Supira personnel and RA consultants.
• Represents the company and maintains relationships with medical device reviewers regarding submissions.
• Oversees preparation and maintenance of regulatory files and labeling review for compliance.

Skills

Regulatory affairs

Technical writing

Communication skills

Leadership

Interpersonal skills

Job description

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 working closely with our Supira Regulatory team and our Regulatory consultants. This is a full-time, hybrid position reporting to our office located in Los Gatos, CA.

Responsibilities, Skills & Hands-On Experience:

• 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.

Education & Work Experience:

• 8+ 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.
• US FDA cardiovascular medical device experience is strongly preferred.
• Proficient knowledge of clinical trial strategy, study design and sponsor reporting requirements.
• Hands-on start-up experience is strongly preferred.
• Excellent written and oral communication, technical writing and editing skills.
• Strong organizational, leadership, interpersonal and influencing skills.

Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $150,000 to $180,000 + equity + benefits.