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Manager / Sr. Manager, Regulatory Affairs

Shifamed
Doha, QAT
Full Time
Manager
1 months ago
Regulatory StrategyFDA SubmissionsIDE510(k)EU MDRISO 13485
Free

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About Akura Medical

  • 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™ Thrombectomy System in acute pulmonary embolism patients.
  • 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&D and manufacturing center in Doha, Qatar.

About Shifamed

  • 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.

Description

  • This Manager / Sr. Manager, Regulatory Affairs will serve as a key member of the cross functional team, partnering closely with Clinical, Quality, R&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.

Regulatory Strategy & Product Development

  • Develop and execute global regulatory strategies for Akura Medical's 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.
  • Partner with Quality and R&D teams to ensure compliance with FDA, MDR, ISO 13485, and applicable international requirements.

FDA Regulatory Affairs

  • Lead preparation, review, and submission of U.S. regulatory filings, including IDE's, 510(k)'s, supplements, and other regulatory submissions as applicable.
  • 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 in partnership with Notified Bodies and external regulatory consultants.
  • Lead country specific registration activities and regulatory submissions 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 closely 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 and regions.
  • Participate in investigator meetings, regulatory inspections, audits, and agency interactions.

Agency Interactions & Compliance

  • Represent the 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 and communicate potential impacts to leadership.
  • 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 to ensure regulatory requirements are incorporated throughout the product lifecycle.
  • Provide regulatory leadership for change assessments, design modifications, and lifecycle management activities.
  • 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 within the medical device industry; cardiovascular, endovascular, or interventional products strongly preferred.
  • Direct experience with FDA medical device submissions, including IDE's, PMA's, 510(k)'s, or PMA 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 directly with regulatory agencies, notified bodies, and international health authorities.
  • Familiarity with MENA regulatory pathways (Saudi SFDA, UAE MOHAP/DOH, Qatar MOPH, etc.) is highly desirable.
  • Strong understanding of design controls, risk management, clinical evidence requirements, and regulatory strategy development.
  • Excellent written, verbal, and presentation skills.
  • Ability to thrive in a fast paced, entrepreneurial environment and work effectively across global teams.

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