Manager​/Sr. Manager, Regulatory Affairs

This Manager / Sr. Manager, Regulatory Affairs will serve as a key member of the cross‑functional team, partnering closely with Clinical, Quality, R&D, and Executive Leadership to support U.S. regulatory activities and lead global clinical studies and international market expansion. The ideal candidate brings strong FDA medical device experience combined with hands‑on knowledge of international regulatory pathways, agency interactions, and clinical study support across Europe, the Middle East, and other global markets.

This is a unique opportunity to help shape regulatory strategy for a clinical‑stage medical device company as it expands global clinical activities, and prepares for international commercialization.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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…