Regulatory Affairs Manager

Olympus is recruiting on behalf of BioProtect, its fully owned entity dedicated to advancing prostate cancer care through innovative spacing solutions.

We are recruiting for a Regulatory Affairs Manager, who will be responsible for coordinating regulatory activities during product development and launch, including establishing and assessing regulatory strategies, implementing applicable regulatory requirements, as well as obtaining and maintaining market approval of medical devices in desired markets.

What you will be doing

• Facilitate development of regulatory plans for new product development projects
• Responsible for development, coordination, preparation, and maintenance of US FDA medical device submissions such as Pre-Submissions, 510ks and communicate with FDA reviewers as needed
• Where designated, responsible for development, coordination, preparation, and maintenance of medical device submissions for Canadian Medical Device License submissions and EU medical device Technical Files under Regulation (EU) 2017/745
• Lead development of responses to regulatory authorities’ requests for additional information
• Interface with International Submission Management, Regulatory Affairs Team to support preparation of dossiers for registration for other global markets such as Japan, Asia Pacific region, Middle East region, etc.
• Keep updated with proposed changes to the worldwide regulatory requirements related to our products and processes
• Advising management of changes and communicate regulatory initiatives or changes to other staff
• Responsible for maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management
• Provide support for cross functional initiatives including manufacturing engineering, quality assurance, product development, and clinical affairs as required to assure regulatory compliance

Who we are looking for

We're looking for a strategic Regulatory Affairs professional who is passionate about bringing innovative medical technologies to patients worldwide. You'll be confident navigating complex global regulatory landscapes, developing regulatory strategies, and partnering with cross-functional teams to ensure products achieve and maintain compliance throughout their lifecycle. To be successful in this role, you will bring:

• Bachelors degree in Science, Engineering or a related discipline
• Significant Regulatory Affairs experience within the medical device industry
• Proven experience preparing and managing global regulatory submissions, including 510(k), CE Mark and other market approvals
• A strong track record of developing regulatory strategies and supporting products throughout their entire lifecycle across global markets
• Working knowledge of key regulations and standards, including FDA, EU MDR, ISO 13485 and risk management principles
• Excellent analytical, project management and problem-solving skills, with the confidence to work independently on complex regulatory challenges
• Strong written and verbal communication skills, with the ability to influence and collaborate across global, cross-functional teams
• High ethical standards, sound judgement and a commitment to delivering quality and compliance
• Willingness to travel internationally on occasion

What we offer you

We offer a competitive salary and a locally competitive benefits package designed for employees based in Israel. In addition to statutory employment benefits, you'll have access to company benefits that support your wellbeing, development, and work-life balance. We'll be happy to share the full details during the interview process.

If this role sounds like your next career move, we look forward to receiving your application. Please note, that all application documents should be submitted in English.