Regulation Manager

Regulation Manager

Location: Yokneam, Israel

About Us: We are a leading international company with over 30 years of experience in the development and manufacturing of medical devices. With offices in the USA and Germany, our company is dedicated to innovation and excellence in the healthcare industry. We are ISO13485-certified and our products comply with FDA and CE standards.

Position Overview: We are seeking a highly skilled and experienced Regulation Manager to join our dynamic team in Yokneam, Israel. The ideal candidate will have extensive experience in medical regulatory affairs and a deep understanding of the Medical Device Regulation (MDR). This role is critical in ensuring that our products comply with all regulatory requirements and maintain our reputation for excellence.

Key Responsibilities:

1. Regulatory Compliance:

• Ensure compliance with all relevant medical device regulations, including FDA, CE, ISO13485, and MDR.
• Develop and implement regulatory strategies to support the introduction of new products and modifications to existing products.
• Prepare and submit regulatory filings and documentation to regulatory authorities.

1. Regulatory Knowledge and Expertise:

• Stay current with changes in regulatory requirements and industry standards.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, and Marketing.
• Conduct regulatory risk assessments and provide solutions to mitigate potential compliance issues.

1. Documentation and Reporting:

• Maintain regulatory files and documentation in compliance with regulatory standards.
• Prepare regulatory reports and submissions, ensuring accuracy and completeness.
• Coordinate with external regulatory consultants and agencies as needed.

1. Team Collaboration:

• Work closely with internal teams to ensure regulatory requirements are understood and implemented effectively.
• Provide training and support to staff on regulatory matters.

Required Qualifications:

• Bachelor’s degree in a related field; advanced degree preferred.
• Minimum of 5 years of experience in medical regulatory affairs - A MUST.
• In-depth knowledge of Medical Device Regulation (MDR) and other relevant regulations - A MUST.
• Full proficiency in English, both spoken and written - A MUST.
• Proven experience in preparing and submitting regulatory filings.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.