Regulatory Affairs Director

We are seeking a highly skilled Regulatory Affairs Manager to join our team at GULP – experts united. As a key member of our team, you will be responsible for managing the Regulatory Affairs department, including the preparation, review, processing, and submission of documents to relevant authorities.

Your Key Responsibilities:

• Develop and implement regulatory guidelines to ensure compliance with industry regulations.
• Review and comply with regulatory procedures and workflows to ensure seamless operations.
• Develop optimal strategies for regulatory compliance and risk management.
• Interface with global regulatory authorities and external consultants to ensure effective communication and collaboration.
• Train, mentor, and supervise employees, consultants, and contractors in the area of regulation, and develop the team to ensure continued growth and success.
• Support interdisciplinary teams as an advisor on regulatory issues, providing expert guidance and recommendations.

Your Profile:

• You have successfully completed your studies with a scientific focus.
• Experience in the field of medical devices or in the biotechnology industry is highly desirable.
• Proven experience in actively leading a team and prioritizing work packages for yourself and your team.
• Very good knowledge in the interpretation of regulations, guidelines, policy statements, and the preparation of marketing authorization applications.
• You enjoy working effectively and cooperatively in cross-functional international teams and are fluent in written and spoken German and English.
• You are willing to travel up to 10% of the time and identify with our values of sustainability, openness, and joy.

About GULP – experts united:

We are a dynamic company that values sustainability, openness, and joy. We offer a comprehensive social package, attractive fixed salary, and opportunities for personnel development. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, we encourage you to apply for this exciting opportunity.