Qureos Mentor

Shifamed LLC

<div><div>Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana&trade; Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing NavIQ&trade;, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&amp;D and manufacturing center in Doha, Qatar. To learn more about Akura Medical, please visit www.akuramed.com.<br>
<br>
ABOUT SHIFAMED<br>
Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.<br>
<br>
Description:</div>
<div><br>
This position represents an exciting opportunity to join the Akura team at an early stage where you will creatively design and develop components, both consumable and capital equipment, of a blood clot removal system. The role focuses on mechanical design of various components and assemblies for catheter systems, a console, and cross-functional leadership from concept through high volume manufacturing. You will be responsible for the design, vendor relationships and testing per applicable standards. This is a full-time, on-site position at our Doha, Qatar office.<br>
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Responsibilities, Skills &amp; Hands-On Experience:</div>
<ul><li>Lead design and development of plastic/composite and metallic parts from concept to high volume manufacturing; drive DFM/DFS, manufacturing and tooling decisions with suppliers.</li>
<li>Drive the full mechanical lifecycle: requirements, concepts, prototyping, detailed design, V&amp;V, and transition to production.</li>
<li>Integrate mechanical designs with electronics, firmware, fluid, and user-interface elements in collaboration with cross-functional teams.</li>
<li>Guide analysis (tolerance stacks, FEA, material selection, root-cause) on critical subsystems.</li>
<li>Creative solutions and product designs to satisfy unmet clinical needs in thrombectomy.</li>
<li>Be a primary contributor to the intellectual property position of the company via invention disclosures and prototypes to demonstrate reduction to practice.</li>
<li>Interact with physicians to assist with product demonstrations and product testing.</li>
<li>Effectively document work throughout the development process though design reviews, manufacturing instructions, test methods, and test reports.</li>
<li>Expertise in design and development of medical devices.</li>
<li>Expertise in electromechanical and mechanism design of durable medical devices.</li>
<li>Substantial experience in design of higher volume disposable components.</li>
<li>Substantial experience in design for molding and machining.</li>
<li>Substantial experience in design for manufacturing. Pilot production experience.</li>
<li>Expertise in product, tool and fixture design using SolidWorks.</li>
<li>Performance test apparatus and test method development.</li>
<li>Process development on both a prototype and manufacturing level.</li>
<li>Mentoring and assisting team members with less experience.</li>
<li>Participating in lab and cleanroom environment builds.</li>
<li>Process optimization and design of experiment based on statistical methodology.</li>
<li>Selecting and managing suppliers, including understanding of capabilities, materials, and fabrication processes</li>
<li>Working independently and in a project team setting.</li>
<li>Supporting regulatory filings including writing technical sections and providing general technical input.</li>
</ul>
<div><br>
Education &amp; Work Experience:</div>
<ul><li>Bachelor's Degree or higher in Mechanical/Biomedical Engineering.</li>
<li>At least 15 years of experience in complex product development, including regulated products.</li>
<li>Advanced SolidWorks proficiency.</li>
<li>Demonstrated track record as a lead/principal engineer or product design of medical devices from concept through launch.</li>
<li>Strong expertise in injection molding and RIM molding (part design, materials, DFM, cosmetic and structural considerations).</li>
<li>Strong experience with medical devices under FDA/ISO 13485 or equivalent regulatory frameworks.</li>
<li>Previous experience working with clinical testing, trials, data collection, and statistical analysis.</li>
</ul><div><div>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.</div>
<div></div><div>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.</div></div></div>

Principal Mechanical Design Engineer

<div><div><div>Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana&trade; Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing NavIQ&trade;, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&amp;D and manufacturing center in Doha, Qatar.</div>
<div></div><div>ABOUT SHIFAMED</div>
<div>Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.</div>
</div><div></div><p>Description:</p>
<p></p><p>This Manager / Sr. Manager, Regulatory Affairs will serve as a key member of the cross-functional team, partnering closely with Clinical, Quality, R&amp;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.</p>
<p></p><p>Responsibilities, Skills &amp; Hands-On Experience:</p>
<p><br>
Regulatory Strategy &amp; Product Development:</p>
<ul><li>Develop and execute global regulatory strategies for Akura Medical's thrombectomy and catheter-based cardiovascular technologies.</li>
<li>Serve as regulatory lead on cross-functional product development teams from concept through commercialization.</li>
<li>Provide regulatory guidance on design controls, risk management, verification and validation activities, labeling, and product changes.</li>
<li>Partner with Quality and R&amp;D teams to ensure compliance with FDA, MDR, ISO 13485, and applicable international requirements.</li>
</ul><p>FDA Regulatory Affairs</p>
<ul><li>Lead preparation, review, and submission of U.S. regulatory filings, including IDE's, 510(k)'s, supplements, and other regulatory submissions as applicable.</li>
<li>Monitor evolving FDA requirements and assess impact on development and commercialization plans.</li>
</ul><p>International Regulatory Expansion</p>
<ul><li>Develop regulatory strategies and market access plans for Europe, the Middle East, and other international markets.</li>
<li>Support CE Mark and MDR-related activities in partnership with Notified Bodies and external regulatory consultants.</li>
<li>Lead country-specific registration activities and regulatory submissions across key international markets including Qatar, UAE, Saudi Arabia, and other MENA countries.</li>
<li>Establish and maintain relationships with regulatory authorities, notified bodies, and international regulatory partners.</li>
</ul><p>Clinical &amp; Regulatory Operations</p>
<ul><li>Partner closely with Clinical Affairs to support global clinical studies, including IDE, PMCF, registries, and post-market studies.</li>
<li>Provide regulatory guidance on protocol development, clinical study design, and regulatory approval pathways.</li>
<li>Support regulatory submissions associated with clinical trial approvals across multiple countries and regions.</li>
<li>Participate in investigator meetings, regulatory inspections, audits, and agency interactions.</li>
</ul><p>Agency Interactions &amp; Compliance</p>
<ul><li>Represent the company during interactions with FDA, Notified Bodies, Ministries of Health, and other regulatory authorities.</li>
<li>Support preparation for regulatory inspections and audits.</li>
<li>Maintain awareness of evolving global regulatory requirements and communicate potential impacts to leadership.</li>
<li>Contribute to regulatory intelligence activities and long-term market expansion planning.</li>
</ul><p>Cross-Functional Leadership</p>
<ul><li>Collaborate with Clinical, Quality, Manufacturing, Supply Chain, and R&amp;D teams to ensure regulatory requirements are incorporated throughout the product lifecycle.</li>
<li>Provide regulatory leadership for change assessments, design modifications, and lifecycle management activities.</li>
<li>Support Executive Leadership with regulatory risk assessments, timelines, and strategic planning.</li>
</ul><p>Qualifications &amp; Experience:</p>
<ul><li>Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or related field.</li>
<li>10+ years of Regulatory Affairs experience within the medical device industry; cardiovascular, endovascular, or interventional products strongly preferred.</li>
<li>Direct experience with FDA medical device submissions, including IDE's, PMA's, 510(k)'s, or PMA supplements.</li>
<li>Experience supporting clinical-stage medical device programs and global clinical studies.</li>
<li>Working knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304, and international regulatory frameworks.</li>
<li>Experience interacting directly with regulatory agencies, notified bodies, and international health authorities.</li>
<li>Familiarity with MENA regulatory pathways (Saudi SFDA, UAE MOHAP/DOH, Qatar MOPH, etc.) is highly desirable.</li>
<li>Strong understanding of design controls, risk management, clinical evidence requirements, and regulatory strategy development.</li>
<li>Excellent written, verbal, and presentation skills.</li>
<li>Ability to thrive in a fast-paced, entrepreneurial environment and work effectively across global teams.</li>
</ul><p>Preferred Qualifications:</p>
<ul><li>Experience with thrombectomy, vascular intervention, pulmonary embolism, structural heart, or electrophysiology technologies.</li>
<li>Prior experience supporting regulatory expansion into Europe, the Middle East, and emerging international markets.</li>
<li>Experience participating in FDA meetings, regulatory inspections, and Notified Body audits.</li>
</ul>
<div></div><div><div>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.</div>
<div></div><div>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.</div></div></div>

Manager / Sr. Manager, Regulatory Affairs

<div><div><div>Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana&trade; Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing NavIQ&trade;, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&amp;D and manufacturing center in Doha, Qatar.</div>
<div></div><div>ABOUT SHIFAMED</div>
<div>Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.</div>
</div><div></div><div>Description:</div>
<div><br>
The Clinical Affairs Manager (MENA Region) will serve as the primary clinical and operational lead for establishing and managing clinical trials across multiple countries in the Middle East and North Africa (MENA) region on behalf of Akura Medical. Based in Doha, Qatar, this individual will be responsible for all aspects of clinical study execution in the region from site identification and regulatory submissions through enrollment, data collection, and closeout. The ideal candidate is a highly self-sufficient, resourceful professional who thrives in an entrepreneurial environment with limited on-the-ground infrastructure. A strong preference will be given to candidates with clinical/procedural expertise in interventional cardiology, interventional radiology, or vascular surgery who can provide direct case coverage and physician-level technical support for interventional procedures alongside treating physicians.<br>
</div><div>Responsibilities, Skills &amp; Hands-On Experience:</div>
<div></div><div>Regional Clinical Trial Setup &amp; Management</div>
<ul><li>Serve as the primary operational lead for clinical studies in the MENA region for both NavIQ and Akura Medical&rsquo;s PE thrombectomy device programs.</li>
<li>Lead the planning, design, and execution of clinical studies (IDE, post-market, PMCF, registries, and observational studies) in alignment with business and regulatory strategy.</li>
<li>Ensures the project is planned and conducted in accordance with all applicable regulations, standard operating procedures, and good clinical practices (GCP).</li>
<li>Develop, review, and manage clinical study documentation, including protocols, informed consent forms, case report forms (CRFs), statistical plans (as applicable), and clinical trial agreements.</li>
<li>Coordinate site identification, evaluation, selection, initiation, monitoring, and close‑out activities across multiple MENA countries (including Qatar, UAE, Saudi Arabia, Egypt, and others as applicable).</li>
<li>Drive all site start-up activities including regulatory and ethics committee (EC/IRB) submissions, budget negotiations, and contract finalization.</li>
<li>Manage and maintain inspection-ready Trial Master File (TMF) and related clinical documentation in compliance with applicable regulations.</li>
<li>Provide oversight of site performance, enrollment, data quality, and protocol compliance.</li>
<li>Develops detailed project plans, and monitors project milestones against performance indicators.</li>
<li>Coordinate investigational device shipments, accountability logs, and supply chain logistics within the region.</li>
<li>Plans, directs, creates, and communicates the study timeline including but not limited to generating reports to provide regular status updates to the US-based clinical team and senior management.</li>
</ul><div>Vendor &amp; Budget Oversight</div>
<ul><li>Manage and oversee clinical research organizations (CROs), laboratories, and other vendors to ensure delivery of contracted services.</li>
<li>Develop and manage study budgets, forecasts, and resource plans; monitor expenditures against approved budgets.</li>
<li>Identify and mitigate operational, timeline, and budgetary risks.</li>
</ul><div>Regulatory &amp; Compliance</div>
<ul><li>Navigate country-specific regulatory landscapes across MENA to obtain necessary approvals for investigational device studies.</li>
<li>Ensure all clinical activities comply with ICH GCP, ISO 14155, local regulatory requirements, and sponsor SOPs.</li>
<li>Support preparation of regulatory submissions, audits, and inspections.</li>
<li>Prepare sites for potential regulatory inspections; serve as the primary regional contact for regulatory queries.</li>
<li>Manage risk assessment and mitigation.</li>
</ul><div>Clinical &amp; Physician Support</div>
<ul><li>Provide direct procedural support and case coverage alongside interventional cardiologists, interventional radiologists, and vascular surgeons performing PE thrombectomy procedures using NavIQ and Akura devices (preferred).</li>
<li>Train physicians, clinical staff, and coordinators on device use, study protocols, and data collection requirements.</li>
<li>Serve as the primary technical and clinical liaison between study sites and the sponsor.</li>
<li>Attend cases as needed and provide real-time guidance and troubleshooting support in the catheterization lab or hybrid OR.</li>
</ul><div>Cross-Functional Collaboration</div>
<ul><li>Provide guidance, training, and operational oversight to Clinical Research Associates (CRAs) and other study team members, as applicable.</li>
<li>Contribute to continuous improvement of clinical operations processes, procedures, and best practices.</li>
<li>Work closely with US-based clinical affairs, regulatory, R&amp;D, and quality teams to align regional activities with overall program goals.</li>
<li>Support planning and execution of investigator meetings, site training sessions, and regional advisory boards.</li>
</ul><div>Education &amp; Work Experience:</div>
<ul><li>Bachelor&rsquo;s degree or higher in Life Sciences, Engineering, or a related healthcare field (advanced degree or clinical licensure preferred e.g., MD, RN, RT, PA, or equivalent).</li>
<li>5&ndash;7 years of experience in clinical research, with minimum of 2 years in the medical device industry.</li>
<li>Demonstrated experience managing pre-market and/or post-market medical device clinical studies.</li>
<li>Hands-on experience in interventional cardiology, interventional radiology, or vascular surgery (either as a clinician, clinical specialist, or field clinical engineer).</li>
<li>Direct experience in the MENA region is highly preferred; ability to provide direct case coverage is a significant advantage.</li>
<li>Familiarity with PE treatment, VTE management, or catheter-based thrombectomy procedures is strongly preferred.</li>
<li>Deep understanding of MENA regulatory environments and experience navigating multi-country clinical submissions (Saudi Arabia SFDA, UAE MOH/DOH, Qatar MOPH, and others).</li>
<li>Strong knowledge of good clinical practice (ICH GCP, ISO 14155), and international regulatory requirements for medical device trials.</li>
<li>Excellent interpersonal skills with demonstrated experience building relationships with KOLs, physicians, and hospital administration across the MENA region.</li>
<li>Strong written and verbal communication skills in English; Arabic language proficiency is a significant plus.</li>
<li>Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with EDC systems and electronic TMF platforms.</li>
<li>Willingness and ability to travel extensively within the MENA region (50&ndash;70% travel expected).</li>
<li>Ability to work effectively in a fast-paced, cross-functional environment.</li>
<li>Demonstrated leadership and problem-solving capabilities.</li>
</ul><div><div>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.</div>
<div></div><div>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.</div></div></div>

Clinical Affairs Manager

Join Shifamed LLC and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Shifamed LLC

About Company

Principal Mechanical Design Engineer

Manager / Sr. Manager, Regulatory Affairs

Clinical Affairs Manager