Head of regulatory affairs

Approach People Recruitment; Niort; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

A recruitment agency in France is seeking a Head of Regulatory Affairs to lead a team focused on ensuring compliance for medical devices. The ideal candidate will have over 10 years of experience in regulatory affairs, along with a strong understanding of local and international regulations like FDA and EMA. Excellent leadership skills and proficiency in English and German are required, with French being a plus. This role involves managing regulatory submissions, strategic guidance, and collaboration with various departments.

Qualifications

• At least 10 years experience in regulatory affairs, preferably in medical devices.
• In-depth knowledge of local and international regulations related to medical devices.
• Proficiency in English and German, French is an advantage.

Responsabilités

• Manage and lead the regulatory affairs team.
• Develop and implement regulatory strategies for compliance.
• Ensure timely submission of regulatory filings.
• Evaluate regulatory requirements for new products.
• Manage interactions with regulatory agencies.
• Maintain regulatory surveillance for new developments.
• Collaborate with internal teams for compliance processes.
• Participate in internal and external audits.

Connaissances

Leadership

Regulatory Affairs Knowledge

Communication Skills

Team Management

Collaboration

Formation

University degree in life sciences or biomedical engineering

Description du poste

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 agencieslandais 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 aагрузка 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.