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:
1. Manage and lead the regulatory affairs team, including activity planning, goal setting, and performance evaluation.
2. Develop and implement regulatory strategies to ensure compliance with local and international standards.
3. Ensure timely and effective submission of regulatory filings to relevant authorities, including new product approvals, renewals, and modifications.
4. Evaluate regulatory requirements for new products and changes to existing products, providing strategic guidance to the product development team.
5. Manage interactions with regulatory agencies and external partners, ensuring effective and positive relationships.
6. Maintain constant regulatory surveillance to identify new requirements and potential regulatory developments impacting the company.
7. Collaborate with internal teams to develop and implement regulatory compliance management processes and systems.
8. Participate in internal and external audits related to regulatory affairs, ensuring appropriate corrective and preventive actions are implemented.
9. Provide regulatory expertise and guidance to other departments within the company, including training on applicable regulatory requirements.
Your profil:
10. University degree in life sciences, biomedical engineering, or a related field.
11. At least 10 years experience in regulatory affairs, preferably in the medical devices sector.
12. In-depth knowledge of local and international regulations related to medical devices, such as FDA, EMA, and European directives.
13. Proven experience in team management and leadership.
14. Excellent communication skills and demonstrated ability to work collaboratively with multifunctional teams.
15. Ability to work independently, manage priorities, and meet tight deadlines.
16. Proficiency in English and German, both spoken and written; proficiency in french would be an advantage.