Head of regulatory affairs

As the Head of Regulatory Affairs, you will be responsible for overseeing and leading the regulatory affairs team for a company specializing in medical devices. You will work closely with the research and development, quality, manufacturing, marketing, and sales departments to ensure regulatory compliance for all products and processes.

Responsibilities:

• Manage and lead the regulatory affairs team, including activity planning, goal setting, and performance evaluation.
• Develop and implement regulatory strategies to ensure compliance with local and international standards.
• Ensure timely and effective submission of regulatory filings to relevant authorities, including new product approvals, renewals, and modifications.
• Evaluate regulatory requirements for new products and changes to existing products, providing strategic guidance to the product development team.
• Manage interactions with regulatory agencies and external partners, ensuring effective and positive relationships.
• Maintain constant regulatory surveillance to identify new requirements and potential regulatory developments impacting the company.
• Collaborate with internal teams to develop and implement regulatory compliance management processes and systems.
• Participate in internal and external audits related to regulatory affairs, ensuring appropriate corrective and preventive actions are implemented.
• Provide regulatory expertise and guidance to other departments within the company, including training on applicable regulatory requirements.

Your profil:

• University degree in life sciences, biomedical engineering, or a related field.
• At least 10 years experience in regulatory affairs, preferably in the medical devices sector.
• In-depth knowledge of local and international regulations related to medical devices, such as FDA, EMA, and European directives.
• Proven experience in team management and leadership.
• Excellent communication skills and demonstrated ability to work collaboratively with multifunctional teams.
• Ability to work independently, manage priorities, and meet tight deadlines.
• Proficiency in English and German, both spoken and written; proficiency in french would be an advantage.