Head of regulatory affairs Medical devices

Approach People; Lausanne; On-site; CHF 180,000 - 260,000; Full time

Job summary

Approach People Recruitment is seeking a Head of Regulatory Affairs in Lausanne to lead the regulatory team and ensure compliance for medical devices. You will collaborate with R&D, quality, manufacturing, marketing and sales to align regulatory strategies and submissions.

The role requires a minimum of 10 years in regulatory affairs, strong leadership, and fluency in English and German, with French a plus. This on-site position offers opportunities to shape regulatory programs across markets.

Qualifications

• Minimum 10 years of regulatory affairs experience in medical devices.
• In-depth knowledge of FDA, EMA and European directives.
• Proven leadership and team management experience.
• Excellent written and spoken English and German; French is a plus.

Responsibilities

• Lead regulatory affairs team with planning, goals and performance reviews.
• Develop regulatory strategies to ensure compliance with local and international standards.
• Oversee submissions for new products, renewals and modifications.
• Evaluate regulatory requirements for new products and changes, guiding product development.
• Manage interactions with regulatory agencies and external partners.
• Monitor regulatory developments and ensure compliance processes.
• Collaborate to implement regulatory compliance management systems.
• Support internal and external audits and ensure CAPA actions.
• Provide regulatory guidance and training to other departments.

Skills

Regulatory leadership

Team management

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Communication skills

Education

University degree in life sciences

Job description

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.