Senior RA Program Lead

Description:

Biosense Webster R&D Haifa Technology Center (HTC) is located in Yokneam, Israel. The HTC teams partner with leading physicians from around the globe to develop innovative MedTech solutions that improve the quality of care for patients worldwide.

The company's work is built on a proud legacy of leadership in electrophysiology. What began in the 1990’s with the founding of Biosense has evolved to present-day expertise driving best-in-class solutions in cardiac ablation, stroke care, intracardiac imaging and navigated ENT surgery.

Innovation is at the forefront at the Haifa Technology Center. HTC has been the top patent applicant in Israel for a decade. To fuel its innovation, experts in systems engineering, software integration, image integration, ultrasound capabilities, 3D printing and miniature sensors work collaboratively to create solutions that improve physician workflow and patient outcomes. HTC is also embracing the future of patient care by pioneering next-generation digital solutions, such as cloud-based applications that are powered by artificial intelligence.

A culture of continuous learning gives HTC employees fresh perspective to fuel continuous innovation and growth. The company embraces the unique perspectives, backgrounds and ideas of its employees, and provides them a fascinating career path and an opportunity to impact patients' lives.

We are seeking a highly motivated and detail-oriented Regulatory Affairs Sr. Program Lead to join our global team. The ideal candidate will be responsible for the preparation and submission of regulatory documentation worldwide, ensuring compliance with authorities and regulatory bodies. Additionally, the candidate will be involved in maintaining registration files, renewing registrations, and updating documents in accordance with regulatory changes. The role also includes providing regulatory support to development projects, crafting regulatory strategies, and assisting departments throughout the product lifecycle.

Responsibilities:

• Preparation and submission of registration files for US, EU and WW, organizing documents according to regulatory guidelines.
• Maintenance of registration files, including renewals and ongoing document updates in response to regulatory changes.
• Support for development projects, regulatory strategy formulation, and ongoing regulatory assistance to departments throughout the product lifecycle.
• Understanding of the quality system for medical devices (ISO 13485) and medical device regulations (MDR, MDSAP, MDD, FDA).
  
  

• Academic qualification – preference for a degree in Quality Assurance, Life Sciences, or Biomedical Engineering.
• Experience of at least 5 years in regulatory affairs of Class II, and Class III Medical Device.
• Experience working with ISO 13485:2016 standard!
• Experience in writing and submitting documents to regulatory bodies in Europe, USA.
• Experience in writing and submitting documents to regulatory bodies in China and Japan – an advantage!
• High proficiency in English, both reading and writing, including technical writing.
• High motivation for self-learning, and great team player
• Lead auditor-an advantage