Regulatory Affairs Medical Devices משרות

KeyMed (Medical & Industrial Equipment) Ltd. (OKM) | Regulatory Affairs

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

As Regulatory Affairs Manager, you 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.

Your responsibilities

• 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

Your qualification

• 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

Your competencies

• Patient Focus - We put patients at the heart of everything
  - Integrity - We do the right thing
  - Innovation - We look for new ways to make things better
  - Impact - We take accountability and get things done
  - Empathy - We care for one another and work together

Your benefits

• 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.

Further information:

We value the diversity of individuals, perspectives, and lifestyles, and prioritise inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.

We warmly encourage all who wish to bring their talents to this role, to apply.