Principal Regulatory Affairs Specialist

Shifamed; Los Gatos (CA); Hybrid; USD 150,000 - 180,000; Full time

Benefits offered by this job

Equity

Benefits

Job summary

Shifamed is seeking a Principal Regulatory Affairs Specialist in Los Gatos, CA to lead US, EU, and Japan regulatory activities for a class III mechanical circulatory support device. The role focuses on submission strategy, planning, and writing with Supira Medical team and consultants.

Responsibilities include writing major submissions (IDE, PMA, EU Design Dossiers, Shonin), coordinating priorities, guiding team, and ensuring regulatory compliance; hybrid work, competitive salary, equity.

Qualifications

• 10+ years in medical device regulatory affairs.
• Experience with IDE, PMA, EU Design Dossiers, and Japanese Shonin.
• Strong US/EU/Japan regulation knowledge and writing skills.
• FDA cardiovascular device experience preferred.
• Start-up/consulting exposure a plus.

Responsibilities

• Lead major regulatory submissions for US, EU, and Japan.
• Structure and manage submission strategies and timelines.
• Provide guidance to Supira team and consultants.
• Draft, review and edit submissions.
• Represent the company with regulators and stakeholders.
• Oversee labeling review and internal regulatory docs.
• Promote continuous improvement in quality and regulatory processes.

Skills

Regulatory affairs

PMA submissions

Global regulatory knowledge

Job description

Position:Principal Regulatory Affairs Specialist

Location: Los Gatos, CA

Job Id:676

# of Openings:1

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.

• 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

• 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.
• 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.

The base salary range for this full-time position is between $150,000 to $180,000 + equity + benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to [e-mail].