Principal Regulatory Affairs Specialist

Los Gatos, CA - USA

Monthly Salary: $ 175000 - 200000

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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 .

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.

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.
Directs and coordinates activities of Supiras 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 followup 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:

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 PMAs 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.
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.
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.

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 $175000 - $200000 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

Required Experience:

Staff IC

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 Supiras 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 followup 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:

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 PMAs 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.
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.
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.

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

Required Experience:

Staff IC