Job Description/Specification:
Join Akura Medical, a Shifamed portfolio company, and play a key role in advancing innovative cardiovascular medical devices. This position leads global regulatory strategy, supports international clinical studies, and drives product approvals across the U.S., Europe, and the Middle East.
✅ Key Responsibilities
- Develop and execute global regulatory strategies for medical devices.
- Lead FDA submissions, including IDE, 510(k), PMA, and related regulatory filings.
- Manage regulatory approvals across Europe and MENA markets.
- Support global clinical studies and regulatory compliance.
- Collaborate with R&D, Clinical, Quality, Manufacturing, and Executive teams.
- Represent the company during FDA, Notified Body, and health authority interactions.
- Ensure compliance with FDA, EU MDR, ISO 13485, and international standards.
- Provide regulatory guidance throughout the product lifecycle.
🎓 Requirements
- Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or a related field.
- 10+ years of Regulatory Affairs experience within the medical device industry.
- Strong experience with FDA submissions (IDE, PMA, 510(k)).
- Knowledge of EU MDR, ISO 13485, ISO 14971, and global regulatory frameworks.
- Experience supporting international regulatory approvals and clinical studies.
- Excellent communication, leadership, and stakeholder management skills.
👥 Who Can Apply?
This role is suitable for:
- Regulatory Affairs Managers
- Senior Regulatory Affairs Specialists
- Medical Device Regulatory Professionals
- Clinical & Regulatory Affairs Managers
- Biomedical Engineers with regulatory expertise
- Regulatory Consultants specializing in cardiovascular devices
🌍 Scope of the Role
As a Manager / Senior Manager – Regulatory Affairs, you will lead regulatory activities from product development through commercialization. You'll shape global regulatory strategies, support clinical trials, manage submissions across multiple international markets, and collaborate with cross-functional teams to bring life-saving cardiovascular technologies to patients worldwide.
This role offers exposure to FDA, EU MDR, and Middle East regulatory authorities, making it ideal for experienced regulatory professionals seeking global responsibility.
🌟 Why Join Akura Medical?
- Work on cutting-edge cardiovascular and thrombectomy technologies.
- Be part of a rapidly growing clinical-stage medical device company.
- Lead global regulatory strategy across multiple international markets.
- Collaborate with world-class engineering, clinical, and executive teams.
- Contribute to expanding R&D and manufacturing operations in Qatar.
📈 Career Growth
Successful candidates can progress into:
- Director of Regulatory Affairs
- Global Regulatory Affairs Director
- Vice President – Regulatory Affairs
- Clinical & Regulatory Affairs Director
- Head of Global Regulatory Strategy
🎁 Benefits
- Competitive compensation package.
- Professional development and international exposure.
- Opportunity to work on breakthrough medical technologies.
- Collaborative and innovation-driven work environment.
- Long-term career growth within a global medical device organization.
❓FAQs
Q: Is medical device regulatory experience required?
Yes. Candidates should have significant Regulatory Affairs experience within the medical device industry.
Q: Is FDA submission experience mandatory?
Yes. Hands-on experience with IDE, PMA, 510(k), or similar FDA submissions is required.
Q: Is experience in the Middle East beneficial?
Yes. Familiarity with regulatory pathways in Qatar, UAE, Saudi Arabia, or other MENA countries is highly desirable.
Q: Which product areas are preferred?
Experience in cardiovascular, endovascular, thrombectomy, vascular intervention, pulmonary embolism, structural heart, or electrophysiology devices is preferred.