Job Title: QA/RA Manager Key Responsibilities: Regulatory Compliance and Quality Assurance: · Ensure compliance with EU MDR 2017/745, FDA QSR, ISO 13485, and ISO 14971 standards. · Oversee the maintenance and improvement of the Quality Management System (QMS). · Lead activities related to regulatory submissions, including technical file preparation and updates. · Act as the primary point of contact for regulatory inspections and audits. · Provide guidance on risk management processes in line with ISO 14971 to ensure patient safety. · Monitor changes in regulations and implement necessary updates to processes and documentation. Quality Systems Development: · Develop and maintain quality engineering methodologies to ensure product compliance. · Support post-market surveillance activities, including adverse event reporting and vigilance. · Lead internal and supplier audits, ensuring effective corrective and preventive actions (CAPA). · Collaborate with cross-functional teams to ensure compliance throughout the product lifecycle. · Measure and improve the quality of internal and external components and suppliers. Project Support: · Support design and development teams with quality and regulatory guidance. · Ensure proper execution of design control and validation activities for new and existing products. · Provide input on usability and human factors engineering to meet regulatory expectations. · Lead the creation and implementation of post-market surveillance plans. Qualifications and Skills: · Bachelor's degree in Engineering, Quality Assurance, Regulatory Affairs, or a related field. · 5 years of experience in a QA/RA role within the medical device industry. · In-depth knowledge of EU MDR, ISO 13485, ISO 14971, and related regulatory standards. · Proven experience managing QMS in a regulated environment. · Strong understanding of risk management principles and regulatory submissions. · Excellent analytical, organizational, and communication skills. · Ability to lead and influence cross-functional teams. · Experience with regulatory inspections and audits is a plus.