Manager / Sr. Manager, Regulatory Affairs

About the company

Akura Medical, part of the Shifamed portfolio, is developing a differentiated solution for treating venous thromboembolism (VTE), a condition that affects up to 900,000 people in the United States each year. The company has secured U.S. IDE approval for its QUADRA-PE study, which is assessing the Katana™ Thrombectomy System in patients with acute pulmonary embolism. In parallel, Akura is building NavIQ™, a software platform that converts CT angiograms into 3D pulmonary vascular models to improve visualization, procedural planning, and clot assessment, with the goal of improving safety, effectiveness, and ease of use. The company has also completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, to support a joint venture along with a new R&D and manufacturing center in Doha, Qatar.

Shifamed, founded in 2009 by serial entrepreneur Amr Salahieh, is a privately held medical device innovation hub focused on creating novel products for unmet needs in cardiology and ophthalmology.

Role overview

The Manager / Sr. Manager, Regulatory Affairs will play a central role in a cross-functional environment, working closely with Clinical, Quality, R&D, and Executive Leadership teams. The position supports U.S. regulatory activity while also driving global clinical studies and international market expansion. The right candidate will bring deep FDA medical device experience together with practical knowledge of international regulatory routes, agency engagement, and clinical study support across Europe, the Middle East, and other global markets. This is an opportunity to help shape regulatory strategy for a clinical-stage medical device organization as it expands clinical operations and prepares for commercialization in international markets.

Key responsibilities

• Create and implement global regulatory plans for Akura Medical’s thrombectomy and catheter-based cardiovascular technologies.
• Act as the main regulatory partner on cross-functional development programs from early concept through commercialization.
• Advise on design controls, risk management, verification and validation, labeling, and product modifications.
• Work with Quality and R&D to align products and processes with FDA, MDR, ISO 13485, and other relevant international standards.
• Lead the drafting, review, and filing of U.S. regulatory submissions such as IDEs, 510(k)s, supplements, and related filings as needed.
• Track changes in FDA expectations and evaluate how they may affect development and launch plans.
• Build regulatory strategies and market-entry plans for Europe, the Middle East, and other international regions.
• Support CE Mark and MDR activities by coordinating with Notified Bodies and outside regulatory specialists.
• Drive country-level registrations and regulatory filings in markets including Qatar, the UAE, Saudi Arabia, and additional MENA countries.
• Develop and maintain relationships with regulators, notified bodies, and international regulatory partners.
• Partner with Clinical Affairs on global studies, including IDEs, PMCF, registries, and post-market research.
• Guide protocol development, study design, and the regulatory path for clinical programs.
• Support submissions needed for clinical trial approvals across multiple countries and regions.
• Take part in investigator meetings, inspections, audits, and regulatory agency discussions.
• Represent the organization in communications with the FDA, Notified Bodies, Ministries of Health, and other authorities.
• Help prepare for audits and regulatory inspections.
• Stay current on global regulatory developments and share potential business impact with leadership.
• Contribute to regulatory intelligence and long-term planning for market expansion.
• Work with Clinical, Quality, Manufacturing, Supply Chain, and R&D teams to ensure regulatory needs are built into the full product lifecycle.
• Provide leadership on change assessments, design updates, and lifecycle management activities.
• Support Executive Leadership with regulatory risk reviews, timelines, and strategic planning.

Requirements

• A bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or a closely related discipline.
• At least 10 years of regulatory affairs experience in the medical device industry, ideally with cardiovascular, endovascular, or interventional products.
• Direct hands-on experience with FDA medical device submissions such as IDEs, PMAs, 510(k)s, or PMA supplements.
• Background supporting clinical-stage medical device programs and global clinical studies.
• Working knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304, and broader international regulatory frameworks.
• Experience dealing directly with regulators, notified bodies, and international health authorities.
• Exposure to MENA regulatory pathways, including Saudi SFDA, UAE MOHAP/DOH, and Qatar MOPH, is strongly preferred.
• Solid understanding of design controls, risk management, clinical evidence expectations, and regulatory strategy development.
• Strong written, spoken, and presentation communication skills.
• Ability to succeed in a fast-moving, entrepreneurial setting and collaborate effectively across global teams.
• Preferred: experience with thrombectomy, vascular intervention, pulmonary embolism, structural heart, or electrophysiology technologies.
• Preferred: prior work supporting regulatory expansion into Europe, the Middle East, and emerging international markets.
• Preferred: participation in FDA meetings, regulatory inspections, and Notified Body audits.

Additional information

Salary ranges are determined based on the role, level, and location. Final placement within the range depends on job-related knowledge, location, skills, experience, relevant education, and training or certifications.

Notice to candidates

Shifamed and its portfolio companies do not interview candidates or issue offers through mobile web chat apps. Any such activity should be reported to hr@shifamed.com.