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.