RA Manager

Company Description

Endospan is a pioneering medical device company headquartered in Herzliya, Israel, specializing in the endovascular repair of aortic arch diseases such as aneurysms and dissections. The company’s flagship product, the NEXUS® Aortic Arch Stent Graft System, is the first CE-approved off-the-shelf branched endovascular solution for aortic arch repair. Designed to address the unique challenges of the aortic arch anatomy, the NEXUS® system provides stable anatomical anchoring and atraumatic sealing for a wide range of pathologies. Endospan’s innovations aim to provide less invasive and safer treatment alternatives for patients worldwide. For more details, visit www.endospan.com.

Role Description

We are seeking an experienced and dynamic Regulatory Affairs Manager to lead our regulatory strategy. The ideal candidate will have strong experience with EU MDR and FDA requirements. This key leadership role will be responsible for developing and executing regulatory strategies, ensuring compliance with EU MDR regulations, and overseeing all regulatory activities to support product development and commercialization. The position reports to the QA/RA Director.

Key Responsibilities:

Regulatory Strategy and Compliance:

  - Develop and implement regulatory strategies to ensure compliance with EU MDR requirements.

  - Lead the transition from MDD to MDR for existing products and ensure timely approvals for new products.

  - Stay current with EU MDR regulations and guidance, and communicate changes to the relevant teams.

Regulatory Submissions and Approvals:

  - Prepare, review, and submit regulatory documentation for product approvals in the EU.

  - Manage interactions with notified bodies and regulatory agencies.

  - Ensure that all regulatory submissions are accurate, complete, and submitted on time.

Cross-Functional Collaboration:

-         Work closely with R&D, Quality Assurance, Clinical Affairs, and Marketing teams to ensure regulatory requirements are met.

-         Provide regulatory guidance throughout the product development lifecycle.

-         Facilitate the integration of regulatory requirements into product design and development.

 Audit Leadership:

- Lead and manage internal and external regulatory audits, including those by notified bodies and other regulatory agencies.

- Develop and implement audit plans and schedules.

       - Ensure audit readiness and compliance with all relevant regulatory standards.

        -Address audit findings and implement corrective and preventive actions (CAPAs) in a timely manner.

       - Report audit outcomes to senior management and ensure continuous improvement based on audit feedback.

Regulatory Intelligence and Advocacy:

  - Monitor and analyze regulatory trends, policies, and changes in the EU and globally.

  - Advocate for Endospan's interests in industry associations and regulatory forums.

  - Provide regulatory risk assessments and strategic recommendations to senior management.

Qualifications

- Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred.

- Minimum of 10 years of regulatory affairs experience in the medical device industry, with a focus on EU regulations.

- Proven experience in leading the transition from MDD to MDR.

- Strong knowledge of EU MDR regulations, guidance, and standards.

- Demonstrated success in obtaining regulatory approvals for Class III medical devices.

- Excellent written and verbal communication skills in English; proficiency in Hebrew is a plus.

- Ability to work effectively in a fast-paced, cross-functional environment.