Shifamed · 14 hours ago
Sr. Manager, Regulatory Affairs
United States
Full-time
Remote
Senior Level, Lead/Staff
$175K/yr - $200K/yr
10+ years expShifamed is a medical device innovation hub focused on developing novel medical products. They are seeking a Sr. Manager of Regulatory Affairs to oversee regulatory activities for a breakthrough mechanical circulatory support system, responsible for submission strategy and coordination with regulatory bodies.
Health CareMedical Device
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
Qualification
Required
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
Preferred
US FDA cardiovascular medical device experience is strongly preferred
Hands-on start-up experience is strongly preferred
Benefits
Equity
Benefits
Company
Shifamed
Shifamed is a progressive medical technology incubator that combines human-centered design.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Claudio Argento
CTO
Mariam Maghribi
Chief Business Officer
Recent News
2025-10-01
2025-08-13
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