Our client is looking for a Regulatory Affairs Director to lead their Regulatory Affairs team based in Lausanne. The Regulatory Affairs Director will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations and standards, facilitating the timely approval and commercialisation of medical devices.
Responsibilities:
- Develop and execute regulatory strategies for new product development, submissions, and post-market compliance activities, ensuring alignment with business objectives and regulatory requirements.
- Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, quality assurance, clinical affairs, and marketing, throughout the product lifecycle.
- Prepare and submit regulatory submissions to health authorities, including 510(k), CE Mark, and other regulatory filings, and manage interactions with regulatory agencies to facilitate product approvals and clearances.
- Monitor and interpret changes in global regulations and standards related to medical devices, assessing the impact on product development and commercialization strategies.
- Lead regulatory intelligence activities to anticipate regulatory trends and developments, providing recommendations and insights to senior management.
- Manage regulatory aspects of clinical studies and post-market surveillance activities, ensuring compliance with regulatory requirements and timely reporting of adverse events.
- Build and maintain relationships with regulatory authorities, industry associations, and external consultants to support regulatory initiatives and advocacy efforts.
- Develop and mentor regulatory affairs team members, providing guidance and support to facilitate their professional growth and development.
Requirements:
- Bachelor's degree in life sciences, engineering, or a related field; advanced degree preferred.
- 8+ years of experience in regulatory affairs within the medical device industry, with a proven track record of success in regulatory submissions and approvals.
- Thorough understanding of global regulations and standards applicable to medical devices, including FDA, EU MDR, and other international requirements.
- Experience leading regulatory strategies for complex medical devices, including Class III and implantable devices, preferred.
- Strong leadership and communication skills, with the ability to influence and collaborate effectively across functions and levels of the organization.
- Strategic mindset with the ability to anticipate challenges and opportunities and develop innovative solutions.
- Fluency in English; additional languages such as French or German are a plus.