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Manager / Sr. Manager, Regulatory Affairs
Akura Medical
Doha, QAT
Full Time
Manager
1 months ago
Regulatory StrategyFDA SubmissionsISO 13485EU MDRISO 14971IEC 62304
Free
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Regulatory StrategyFDA SubmissionsISO 13485
About the Role
Akura Medical seeks a Manager/Sr. Manager of Regulatory Affairs to lead global regulatory strategy for thrombectomy and catheter-based cardiovascular technologies. You will develop and execute regulatory strategies, lead FDA submissions, support international expansion, and partner with cross-functional teams.
Key Skills for This Role
Regulatory StrategyFDA SubmissionsISO 13485EU MDRISO 14971IEC 62304
Responsibilities
- Develop and execute global regulatory strategies for 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
- Lead preparation, review, and submission of U.S. regulatory filings (IDEs, 510(k)s, supplements)
- Develop regulatory strategies and market access plans for Europe, the Middle East, and other international markets
- Support CE Mark and MDR related activities with Notified Bodies
- Lead country specific registration activities across key international markets including Qatar, UAE, Saudi Arabia
- Partner with Clinical Affairs to support global clinical studies
- Represent company during interactions with FDA, Notified Bodies, Ministries of Health
- Contribute to regulatory intelligence and long term market expansion planning
Requirements
- Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or related field
- 10+ years of Regulatory Affairs experience in medical device industry
- Direct experience with FDA medical device submissions (IDEs, PMAs, 510(k)s, or supplements)
- Experience supporting clinical stage medical device programs and global clinical studies
- Working knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304
- Experience interacting with regulatory agencies, notified bodies, and international health authorities
- Strong understanding of design controls, risk management, clinical evidence requirements
- Excellent written, verbal, and presentation skills
- Cardiovascular, endovascular, or interventional product experience strongly preferred
- Familiarity with MENA regulatory pathways (Saudi SFDA, UAE MOHAP/DOH, Qatar MOPH) highly desirable
Full Job Posting
About Akura Medical
- Akura Medical is advancing a differentiated platform for treatment of venous thromboembolism (VTE).
- Recently received US IDE approval for QUADRA PE study evaluating Katana Thrombectomy System.
- Developing NavIQ software platform for 3D pulmonary vascular models.
- Completed $53 million Series C first close led by Qatar Investment Authority.
About Shifamed
- Founded in 2009 by Amr Salahieh, Shifamed is a medical device innovation hub.
- Focus on cardiology and ophthalmology.
Regulatory Strategy & Product Development
- Develop and execute global regulatory strategies for 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, labeling, and product changes.
- Partner with Quality and R&D teams to ensure compliance with FDA, MDR, ISO 13485, and international requirements.
FDA Regulatory Affairs
- Lead preparation, review, and submission of U.S. regulatory filings including IDEs, 510(k)s, supplements.
- 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 with Notified Bodies.
- Lead country specific registration activities 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 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.
- Participate in investigator meetings, regulatory inspections, audits, and agency interactions.
Agency Interactions & Compliance
- Represent 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.
- 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.
- Provide regulatory leadership for change assessments, design modifications, and lifecycle management.
- Support Executive Leadership with regulatory risk assessments, timelines, and strategic planning.
Qualifications & Experience
- Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or related field.
- 10+ years of Regulatory Affairs experience in medical device industry; cardiovascular preferred.
- Direct experience with FDA medical device submissions including IDEs, PMAs, 510(k)s, or 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 with regulatory agencies, notified bodies, and international health authorities.
- Familiarity with MENA regulatory pathways (Saudi SFDA, UAE MOHAP/DOH, Qatar MOPH) highly desirable.
- Strong understanding of design controls, risk management, clinical evidence requirements.
- Excellent written, verbal, and presentation skills.
- Ability to thrive in fast paced, entrepreneurial environment.
Preferred Qualifications
- Experience with thrombectomy, vascular intervention, pulmonary embolism, structural heart, or electrophysiology technologies.
- Prior experience supporting regulatory expansion into Europe, Middle East, and emerging markets.
- Experience participating in FDA meetings, regulatory inspections, and Notified Body audits.
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