VP Clinical affairs and Regulation

Responsibilities:

Develop and implement company regulatory and clinical trials strategies.

Ensure company compliance with relevant regulation, and international standards for Israel/USA/Europe

Coordinate with cross-functional teams to ensure compliance with regulatory and clinical requirements.

Provide expertise in clinical trial processes.

Prepare and submit regulatory submissions.

Communicate and collaborate effectively with stakeholders, including regulatory agencies and internal departments.

Requirements:

2nd or 3rd degree in engineering or life science or other relevant topics

Over 8 years of hands-on experience in regulatory and clinical affairs management for a Medical Device company

Experience developing and executing regulatory strategy for both the US and EU

Familiarity with normal databases, statistics– an advantage

Hands on experience designing and leading clinical studies and working closely with luminary sites

Experienced in planning and executing medical device FDA regulatory pathway, including interactions with the FDA.

Willingness to travel abroad for clinical trials as required

Fluent English