- Leading the preparation and submission of regulatory approvals in the markets served by the company. Including (but not limited to): EU, USA, China, Canada, Australia, New Zealand, Israel, Middle East, Korea
- Participating in ensuring compliance with all applicable standards and regulations for company’s medical devices
Experience, Skills and Abilities
- Strong background in regulatory affairs for medical devices, with at least 5 years of relevant experience.
- Experience in the medical devices industry essential
- Good knowledge and experience of EU regulations and guidance required
- Good knowledge of ISO13485 and ISO14971 highly desirable
- Experience of FDA 510(k) submissions highly desirable
- Experience of regulations in Asia, Canada, Australia, Middle East desirable
- Educated to degree level in a relevant discipline
- Good time management, thoroughness, attention to detail and organisational skills.
- Excellent communication skills, both verbally and in writing, using correct terminology with staff and partners at all levels.
- Self-motivated and able to work independently, but to do so in the context of the wider team.
- Able to understand the context of their role within the commercial objectives of the company, and have the necessary degree of pragmatism, flexibility and sense of urgency to succeed in a small company environment.
For more information contact Carlos Biggemann: