Quality Regulatory Manager

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!

Responsibilities:

• 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.

Requirements and Skills:

• 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.