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/KNOWLEDGE:

• 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

OTHER:

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