Role Overview:
As a Senior Regulatory Affairs Specialist, you will play a pivotal role in ensuring compliance with relevant regulations and standards for Class III implantable devices.
This position presents an exciting opportunity to contribute to the development of a novel cardiovascular device at an early-stage medical device company.
* Develop and maintain product design and technical documentation to meet regulatory requirements.
* Submit high-quality clinical and regulatory files to obtain successful approval from ethical committees and regulatory agencies.
Key Responsibilities:
1. Support the creation and maintenance of regulatory-compliant product design and technical documentation for Class III implantable devices.
2. Develop and submit high-quality clinical and regulatory files to obtain approval from regulatory agencies and ethical committees.
3. Maintain regulatory submissions with authorities, committees, and investigation sites.
4. Assist preparation for inspection by notified bodies and regulatory authorities.
5. Implement and maintain a robust quality system according to ISO 13485, including risk management.
Requirements:
1. Bachelor's degree in science, engineering, or a related field.
2. At least 5 years' experience in Regulatory Affairs within the medical device industry.
3. Extensive knowledge of quality management systems, design controls per ISO 13485, and current international and European regulations/standards for medical devices.