ISOPLUS S.A demonstrates more than 30 years of experience and excellence in the representation, distribution and promotion of natural food supplements and cosmetics in Greece and abroad, possessing a leading position in the Greek market through an extensive sales network.

We are currently looking for a Product Development & Regulatory Affairs Manager to join our team in our Headquarters in Athens.

Main Responsibilities

• Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.
• Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.
• Ensure that all regulatory requirements are met throughout the product lifecycle.
• Prepare and submit regulatory submissions, including but not limited to, product registrations, pre-market notifications, and post-market surveillance reports.
• Liaise with regulatory authorities and act as the primary point of contact during inspections, audits, and regulatory agency interactions.
• Conduct risk assessments and develop mitigation strategies to manage regulatory risks.
• Review and approve product labelling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.
• Provide regulatory guidance and support to internal stakeholders, including product development teams, to ensure that regulatory requirements are incorporated into the development process.
• Monitor and track regulatory compliance metrics and provide regular reports to senior management.
• Maintain a thorough understanding of international regulations in relevant markets and guide the organization regarding international expansion plans.

Key Requirements

• Bachelor's degree in a scientific discipline, engineering, or related field. Master's degree is preferred.
• Minimum of 3-4 years of experience in regulatory affairs within the relevant industry.
• Proven track record of successfully developing and executing regulatory strategies and obtaining regulatory approvals for products.
• In-depth knowledge of relevant regulations and standards, such as FDA regulations, ISO standards, and other applicable regional regulations.
• Experience in interacting with regulatory authorities and managing regulatory inspections and audits.
• Professional certifications in regulatory affairs are a plus.
• Strong understanding of quality systems and the ability to apply regulatory requirements to quality management processes.
• Experience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentation.

 Benefits

• Competitive remuneration package
• Private health insurance
• Learning and development opportunities
• Modern and friendly working environment where teamwork, communication, improvement and reward are fundamental components

If you think you have what it takes, we are looking forward to hearing from you!

*All applications will be treated with strict confidentiality.