Are you ready to take the next step in your Regulatory Affairs and Quality career?
Join a healthcare company at the forefront of innovation in the cardiovascular sector, dedicated to enhancing treatment options for patients worldwide.
We are looking for a Regulatory Affairs/Quality Assurance (RA/QA) Manager to join our client’s team. If you’re passionate about ensuring regulatory compliance and maintaining high-quality standards, we’d love to hear from you!
Create, maintain, control, and archive Quality Management documents to ensure compliance and consistency.
Support the implementation, maintenance, and continuous improvement of the Quality Management System in accordance with ISO 13485.
Prepare for and assist in conducting annual audits, including handling corrective actions where necessary.
Collaborate with the Risk Management Representative to create and maintain Risk Management documents in accordance with ISO 14971.
Contribute to technical file documentation for MDR and EU pivotal submissions, particularly around process validations, biocompatibility, sterilization, and Device Master Records (DMR).
Serve as the Process Validation Representative, creating, maintaining, and controlling process and software validation documents, both internally and with external suppliers.
Assist in conducting internal audits and ensuring compliance with internal and regulatory standards.
Support or manage various QMS processes, such as design and process change management, purchasing, control of non-conforming products, and handling complaints.
Oversee and audit suppliers, ensuring compliance and quality standards are met.
Bachelor’s degree in Medical Engineering or a related field, or equivalent experience.
3-4+ years of experience in Regulatory Affairs and Quality Assurance within the medical device industry.
Familiarity with regulatory standards such as ISO 13485, MDR, and ISO 14971.
Strong communication skills for effective interaction with internal teams and external partners.
Proficiency in English (German skills are a plus).
Experience in managing supplier communication, quality documentation and process validation is highly desirable.
If you're interested in this opportunity and want to take the next step in your RA/QA career, please apply here or contact Hollie Dear at Adaptive Life Science for more information.