Manager / Sr. Manager, Regulatory Affairs

Role overview

This position sits within Akura Medical, a Shifamed portfolio company working on advanced therapies for venous thromboembolism (VTE), a condition impacting up to 900,000 people in the U.S. each year. The company has secured U.S. IDE approval for the QUADRA-PE study of the Katana™ Thrombectomy System in acute pulmonary embolism patients and is also building NavIQ™, a software platform that converts CT angiograms into 3D pulmonary vascular models to improve visualization, procedural planning, and clot assessment. Akura Medical has also completed a $53 million first close of its Series C round, led by the Qatar Investment Authority, to support a joint venture and a new R&D and manufacturing center in Doha, Qatar.

Shifamed, founded in 2009 by entrepreneur Amr Salahieh, is a privately held medical device innovation company focused on developing new products that address unmet clinical needs in cardiology and ophthalmology.

What the role will do

The Manager / Sr. Manager, Regulatory Affairs will be a central contributor on a cross-functional team, working closely with Clinical, Quality, R&D, and executive stakeholders. The role is responsible for supporting U.S. regulatory work, guiding global clinical studies, and enabling international market expansion. It is well suited to someone with deep FDA medical device expertise and practical exposure to global regulatory pathways, agency engagement, and clinical study support across Europe, the Middle East, and other regions.

Regulatory strategy and product development

• Create and implement worldwide regulatory plans for Akura Medical’s thrombectomy and catheter-based cardiovascular products.
• Act as the regulatory owner on cross-functional development programs from early concept through commercialization.
• Advise teams on design controls, risk management, verification and validation, labeling, and product modifications.
• Work with Quality and R&D to help ensure alignment with FDA expectations, MDR, ISO 13485, and relevant international requirements.

U.S. FDA regulatory activities

• Drive the preparation, review, and submission of U.S. regulatory documents such as IDEs, 510(k)s, supplements, and other filings as needed.
• Track changes in FDA expectations and assess how they may affect development and commercialization plans.

International regulatory expansion

• Build regulatory and market access approaches for Europe, the Middle East, and additional global markets.
• Support CE Mark and MDR-related work alongside Notified Bodies and outside regulatory consultants.
• Lead registration and submission activities in countries such as Qatar, the UAE, Saudi Arabia, and other MENA markets.
• Develop and maintain working relationships with regulators, Notified Bodies, and international regulatory partners.

Clinical and regulatory operations

• Partner with Clinical Affairs on global studies including IDE, PMCF, registries, and post-market research.
• Provide regulatory input on protocol development, study design, and approval pathways.
• Support submissions tied to clinical trial approvals in multiple countries and regions.
• Take part in investigator meetings, audits, inspections, and agency interactions.

Agency interaction and compliance

• Represent the company in discussions with the FDA, Notified Bodies, Ministries of Health, and other authorities.
• Help prepare for inspections and audits.
• Stay current on global regulatory changes and communicate likely business impacts to leadership.
• Contribute to regulatory intelligence and long-term expansion planning.

Cross-functional leadership

• Collaborate with Clinical, Quality, Manufacturing, Supply Chain, and R&D teams so regulatory needs are reflected throughout the product lifecycle.
• Guide change assessments, design updates, and lifecycle management activities from a regulatory standpoint.
• Support executive leadership with risk assessments, timelines, and strategic decision-making.

Qualifications

This role requires a bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or a related discipline, along with 10+ years of medical device regulatory affairs experience. Background in cardiovascular, endovascular, or interventional products is strongly preferred. The ideal candidate has direct experience with FDA submissions such as IDEs, PMAs, 510(k)s, or PMA supplements, plus experience supporting clinical-stage programs and global clinical studies.

Working knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304, and broader international regulatory frameworks is expected. Experience working directly with regulatory agencies, Notified Bodies, and international health authorities is also important. Familiarity with MENA pathways such as Saudi SFDA, UAE MOHAP/DOH, and Qatar MOPH is highly desirable.

Strong understanding of design controls, risk management, clinical evidence requirements, and regulatory strategy is required, along with excellent written, verbal, and presentation skills. Success in a fast-moving, entrepreneurial environment and the ability to collaborate effectively across global teams are essential.

Preferred background

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

Additional information

The compensation band for this role is determined by the position level, location, relevant knowledge, skills, experience, education, and certifications. Final pay will depend on the selected candidate’s profile within that range.

Important candidate notice

The company does not interview or make offers through mobile web chat apps. If such contact occurs, it should be reported to hr@shifamed.com.