Regulatory Affairs Specialist

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Skills you'll use

What you'll do

• Plan, establish, implement, maintain, and continuously improve the Quality Management System (QMS) in accordance with EN ISO 13485 and applicable medical device regulatory requirements.
• Drive QMS streamlining and process improvements across functions to ensure effective, efficient, and compliant quality processes throughout the product lifecycle.
• Develop, review, and maintain quality policies, procedures, SOPs, work instructions, forms, and quality records in alignment with regulatory and organizational requirements.
• Ensure effective implementation and maintenance of Design Controls, Document Control, Change Control, Risk Management, CAPA, Non-Conformance, Complaint Handling, Supplier Quality, Training, and other QMS processes.
• Support regulatory compliance with applicable standards and regulations, including US FDA, EU MDR/CE Marking, CDSCO, IEC 60601, IEC 62304, ISO 14971, and other relevant requirements.
• Prepare and maintain regulatory dossiers, Device Master Files/Technical Documentation, and quality-related documentation required for regulatory submissions and product lifecycle activities.
• Work closely with Product Development, Product Transfer, Manufacturing, Engineering, and other cross-functional teams to ensure QMS and regulatory requirements are effectively implemented.
• Provide guidance to cross-functional teams on quality and regulatory requirements at various stages of the medical device product lifecycle.
• Conduct or support internal audits, supplier audits, Notified Body audits, and regulatory inspections, including audit preparation, coordination, response, and closure of observations/findings.
• Lead the identification, investigation, implementation, and effectiveness verification of CAPAs and corrective/preventive actions.

Who can apply

• B.Tech or equivalent educational qualification.
• 3-5 years of experience in Medical Device Quality Assurance, Quality Management Systems, and/or Regulatory Affairs.
• Hands-on or working knowledge of QMS implementation, streamlining, improvement, maintenance, and compliance in accordance with ISO 13485.
• Experience in developing, implementing, reviewing, and maintaining QMS procedures, SOPs, work instructions, and quality records.
• Working knowledge of Design Controls, CAPA, Change Control, Document Control, Non-Conformance, Risk Management, Supplier Quality, Training, Complaint Handling, and other core QMS processes.
• Knowledge of US FDA, EU MDR/CE Marking, CDSCO, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and other applicable medical device regulations and standards.
• Experience supporting regulatory submissions, new medical device registrations, and maintenance of regulatory/technical documentation.
• Experience supporting regulatory inspections, Notified Body audits, internal audits, and supplier audits, including preparation and closure of findings.
• Ability to analyze and interpret regulations, standards, guidance documents, technical procedures, and regulatory requirements and translate them into practical QMS processes.
• Experience in quality metrics, Management Review, CAPA effectiveness, audit readiness, and continuous improvement initiatives.

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