Regulatory Affairs Specialist

Specialist, Regulatory Affairs

Please apply in English only

Novocure is a global medical device company with R&D based in Haifa. The company is growing quickly as it commercializes TTFields therapy: a novel treatment for aggressive cancers using alternating electric fields.

The Regulatory Affairs Specialist will be part of the Global Regulatory Affairs team and will be responsible for supporting the team in the preparation of documentation for regulatory submissions required to market new or modified medical devices. The Regulatory Affairs Specialist will perform regulatory affairs activities, such as the maintenance of regulatory documentation, procedures, and systems designed to ensure that the company’s overall product development process addresses all regulatory requirements, as well as, the objectives of the business. The Regulatory Affairs Specialist will support the company’s regulatory activities related to the entire product lifecycle from new product development to post-market surveillance. The Regulatory Affairs Specialist will also support the global team to ensure compliance with the processes required by the standards and applicable regulations in the US and non-US jurisdictions (Europe, Japan, China, and others as needed). This full-time position reports to the Director, Regulatory Affairs and is placed in our Haifa office, Israel. ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Support in the preparation and management of documentation for global regulatory submissions in a timely manner.
• Support in the preparation of responses to regulatory queries from global regulatory authorities.
• Organization and maintenance of records and correspondence with all parties involved in the regulatory document control center.
• Maintain processes and monitor practices to ensure regulatory compliance.
• Research regulatory issues and provide guidance and advice to colleagues.
• Assist in the research and dissemination of global regulatory intelligence topics.
• Liaise with cross-functional teams such as engineering, QA, supply chain, pre-clinical and clinical development on projects
  
  

• Qualifications:
• MSc degree in life sciences
• Knowledge:
• 5+ years of experience in regulatory affairs and/or QA within the Medical device/ pharmaceutical industry .
• Knowledge of international regulations for the EU, US, Japan, China and others
• Knowledge of the ISO 13485
• Experience in writing procedures and regulatory documents
• Fluent in English, both written and spoken, and other European languages is an advantage
• Ability to work consistently and effectively as part of a team
• Attention to detail
• Ability to work under pressure to meet aggressive deadlines
• Critical thinking, reasoning, and problem-solving capability
• Excellent Office software proficiency
  
  

• Excellent organizational and time management skills
• Highly motivated and quality oriented
• Excellent communication skills