Regulatory Affairs and Quality Assurance Specialist
vor 11 Stunden
ApoQlar is a pioneering medical technology company that revolutionizes the healthcare industry by leveraging cutting-edge technology and innovative solutions.
Job OverviewWe are seeking an experienced Regulatory Affairs and Quality Assurance Specialist to join our team in Hamburg. As a key member of our Regulatory & Quality Management team, you will play a leading role in ensuring our mixed reality platform complies with regulatory and statutory requirements.
Responsibilities- Develop and implement a regulatory strategy to ensure compliance with applicable laws and regulations.
- Maintain and optimize our Quality Management System (QMS) and Regulatory Affairs framework.
- Lead global regulatory approval processes and respond to questions from notified bodies and regulators.
- Implement regulatory requirements in accordance with EU MDR 2017/745.
- Manage risk management activities and collaborate with the risk management team.
- Participate in and support internal and external audits.
- University degree in biomedical science, engineering, pharmacy, or a related field.
- At least 7 years of experience in regulatory affairs and quality management, including FDA submissions.
- Proficient knowledge of EU medical device regulations and ISO 13485.
- Experience in communication with authorities and notified bodies.
- In-depth knowledge of software lifecycle processes and IEC 62304.
- Strong analytical skills and ability to evaluate product compliance.
- Opportunity to work with new and exciting technologies.
- Chance to positively impact the lives of patients, students, and surgeons worldwide.
- Competitive compensation structure and opportunities for growth.
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