Manager / Sr. Manager, Regulatory Affairs

Overview

About Shifamed

Description

Regulatory Strategy & Product Development

• Develop and execute global regulatory strategies for Akura Medical's thrombectomy and catheter-based cardiovascular technologies.
• Serve as regulatory lead on cross-functional product development teams from concept through commercialization.
• Provide regulatory guidance on design controls, risk management, verification and validation activities, labeling, and product changes.
• Partner with Quality and R&D teams to ensure compliance with FDA, MDR, ISO 13485, and applicable international requirements.

FDA Regulatory Affairs

• Lead preparation, review, and submission of U.S. regulatory filings, including IDE's, 510(k)'s, supplements, and other regulatory submissions as applicable.
• Monitor evolving FDA requirements and assess impact on development and commercialization plans.

International Regulatory Expansion

• Develop regulatory strategies and market access plans for Europe, the Middle East, and other international markets.
• Support CE Mark and MDR-related activities in partnership with Notified Bodies and external regulatory consultants.
• Lead country-specific registration activities and regulatory submissions across key international markets including Qatar, UAE, Saudi Arabia, and other MENA countries.
• Establish and maintain relationships with regulatory authorities, notified bodies, and international regulatory partners.

Clinical & Regulatory Operations

• Partner closely with Clinical Affairs to support global clinical studies, including IDE, PMCF, registries, and post-market studies.
• Provide regulatory guidance on protocol development, clinical study design, and regulatory approval pathways.
• Support regulatory submissions associated with clinical trial approvals across multiple countries and regions.
• Participate in investigator meetings, regulatory inspections, audits, and agency interactions.

Agency Interactions & Compliance

• Represent the company during interactions with FDA, Notified Bodies, Ministries of Health, and other regulatory authorities.
• Support preparation for regulatory inspections and audits.
• Maintain awareness of evolving global regulatory requirements and communicate potential impacts to leadership.
• Contribute to regulatory intelligence activities and long-term market expansion planning.

Cross-Functional Leadership

• Collaborate with Clinical, Quality, Manufacturing, Supply Chain, and R&D teams to ensure regulatory requirements are incorporated throughout the product lifecycle.
• Provide regulatory leadership for change assessments, design modifications, and lifecycle management activities.
• Support Executive Leadership with regulatory risk assessments, timelines, and strategic planning.

& Experience

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or related field.
• 10+ years of Regulatory Affairs experience within the medical device industry; cardiovascular, endovascular, or interventional products strongly preferred.
• Direct experience with FDA medical device submissions, including IDE's, PMA's, 510(k)'s, or PMA supplements.
• Experience supporting clinical-stage medical device programs and global clinical studies.
• Working knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304, and international regulatory frameworks.
• Experience interacting directly with regulatory agencies, notified bodies, and international health authorities.
• Familiarity with MENA regulatory pathways (Saudi SFDA, UAE MOHAP/DOH, Qatar MOPH, etc.) is highly desirable.
• Strong understanding of design controls, risk management, clinical evidence requirements, and regulatory strategy development.
• Excellent written, verbal, and presentation skills.
• Ability to thrive in a fast-paced, entrepreneurial environment and work effectively across global teams.

Preferred Qualifications

• Experience with thrombectomy, vascular intervention, pulmonary embolism, structural heart, or electrophysiology technologies.
• Prior experience supporting regulatory expansion into Europe, the Middle East, and emerging international markets.
• Experience participating in FDA meetings, regulatory inspections, and Notified Body audits.
• 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.
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