Job Details Job Description: QA/RA Manager – Medical Devices Company Overview: We are a leading medical device company committed to developing innovative and life-changing solutions that improve patient outcomes and healthcare worldwide. Our products range from advanced medical technologies to diagnostic equipment, all designed to meet the highest quality and safety standards. We are seeking a dynamic and experienced QA/RA Manager to join our team in Denmark and play a pivotal role in ensuring compliance and product excellence. Position Overview: As the QA/RA Manager for our medical device division in Denmark, you will be responsible for overseeing all aspects of Quality Assurance (QA) and Regulatory Affairs (RA) activities to ensure compliance with relevant regulations and standards. You will collaborate closely with cross-functional teams to maintain the highest level of product quality, safety, and regulatory compliance. This is a leadership role that requires a deep understanding of the medical device industry’s regulatory landscape in Denmark and the European Union. Key Responsibilities: Regulatory Compliance: Interpret and stay up-to-date with relevant medical device regulations in Denmark and the EU, including MDR (Medical Device Regulation) and ISO standards. Develop and maintain strategies to ensure products meet regulatory requirements throughout their lifecycle. Prepare and submit regulatory submissions for product approvals and registrations. Quality Assurance: Establish and maintain a comprehensive Quality Management System (QMS) in accordance with applicable standards and regulations. Implement and oversee processes for design control, risk management, CAPA (Corrective and Preventive Actions), and supplier quality management. Conduct internal and external audits to assess compliance and identify areas for improvement. Cross-Functional Collaboration: Work closely with R&D, manufacturing, and other departments to ensure quality and regulatory considerations are integrated into product development and manufacturing processes. Collaborate with international teams to align global QA/RA strategies and initiatives. Documentation and Reporting: Ensure accurate and complete documentation of all QA/RA activities, including maintaining technical files, dossiers, and regulatory submissions. Generate reports and provide updates to senior management regarding QA/RA performance, risks, and opportunities. Training and Development: Provide training and guidance to internal teams on QA/RA principles, regulations, and best practices. Foster a culture of continuous improvement and quality awareness throughout the organization. Qualifications: Bachelor’s degree in a relevant scientific or engineering field; advanced degree preferred. Minimum of 5 years of experience in QA/RA roles within the medical device industry. In-depth knowledge of Danish and EU medical device regulations (MDR) and ISO standards. Proven experience in successfully managing regulatory submissions and interactions with competent authorities. Strong leadership skills with the ability to lead and motivate cross-functional teams. Excellent communication skills, both written and verbal, in English and preferably Danish. Experience with QMS implementation, audit processes, and quality tools. Regulatory certifications (RAC) or equivalent are a plus.