Regulatory Affairs Expert for Medical Device Compliance
7 days ago
We are seeking a skilled Regulatory Affairs Specialist to join our Quality Assurance and Regulatory Affairs department at UNEEG medical A/S. As a Regulatory Affairs Expert, you will play a crucial role in ensuring compliance with legislation and guidance for medical devices.
About the Role- You will be responsible for daily evaluation of customer complaints for reportability, vigilance reporting to authorities, and driving post-market surveillance processes for products on the market.
- You will write post-market surveillance documentation, including PMS plans and periodic safety update reports (PSURs).
- You will participate in projects for changes to products, such as design, manufacturing, and labeling, to ensure regulatory compliance.
- You will create and maintain regulatory documentation for products on the market and develop country submissions.
In this role, you will have the opportunity to work closely with our team to identify and address regulatory challenges and ensure the success of our product portfolio.
Requirements- You should have a master's degree in natural science (biomedical, engineering, or similar) and experience working with medical devices, preferably electronic and software devices.
- You should have experience working with ISO 13485 and regulatory requirements for medical devices, including MDR and FDA CFR 21 part 820.
- You should have basic understanding of design controls and applicable standards and guidelines.
- You should have experience with regulatory submissions and knowledge about vigilance and post-market surveillance processes.
We offer a competitive salary of €60,000 - €80,000 per year, depending on experience, plus benefits and opportunities for professional growth and development.
About UsUNEEG medical A/S is an entrepreneurial and ambitious company specializing in providing the epilepsy community with more accurate knowledge of seizures to support improvement in epilepsy care. We are committed to innovation and excellence in all aspects of our business and strive to create a workplace culture that values diversity, inclusivity, and collaboration.
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