Quality and Regulatory Manager

WE ARE HIRING : Quality & Regulatory Manager

Role Overview

We are seeking an experienced and detail-oriented Quality & Regulatory Manager to lead and manage Quality Assurance (QA), Quality Control (QC), and Regulatory Compliance functions. The ideal candidate will ensure that all products meet internal quality standards, customer expectations, and international regulatory requirements particularly within the medical device manufacturing sector.

The role involves driving continuous improvement across processes, ensuring compliance with ISO standards, and maintaining certifications and regulatory approvals essential for global operations.

Key Responsibilities

Quality Assurance & Control

• Plan, implement, and oversee all quality assurance and control activities for raw materials, in-process materials, and finished products.
• Establish, maintain, and improve ISO 9001 and ISO 13485 quality systems.
• Conduct supplier evaluations and internal audits; ensure readiness for external regulatory and customer audits.
• Investigate customer complaints and lead root-cause analysis, implementing corrective and preventive actions.
• Drive continuous improvement initiatives to enhance product quality, safety, and customer satisfaction.
• Manage calibration and maintenance of quality control equipment.
• Develop and report on quality KPIs including defect rate, yield, and cost of non-quality.
• Lead quality training programs to strengthen organizational quality awareness.

Regulatory Compliance

• Ensure full compliance with all medical device regulatory requirements and certification programs (FDA, CE Mark, EU MDR, FSC, SMETA, etc.).
• Coordinate with regulatory authorities, certification agencies, and internal departments on submissions and audits.
• Maintain up-to-date knowledge of global and local regulatory standards affecting medical device manufacturing.
• Manage documentation, licensing, and audit readiness for all regulatory and compliance activities.
• Identify and address compliance gaps and communicate risks and mitigation plans to management.

Qualifications & Experience

• Bachelors Degree in Polymer Science, Chemistry, Applied Science, or a related field (Masters preferred).
• Minimum 3-5 years of experience in manufacturing or industrial environments, handling QA/QC operations and compliance.
• Proven experience managing ISO 9001 and ISO 13485 systems.
• Lead Auditor Certification in ISO 9001 and ISO 13485 is mandatory.
• Strong familiarity with FDA Licensing, CE Marking, EU MDR, SMETA, and WCA audits.
• Experience leading cross-functional teams in quality or regulatory compliance.
• Excellent analytical, problem-solving, and communication skills.
• Knowledge of laboratory testing, measurement, and calibration methods is an advantage.

Key Competencies

• Strategic leadership with hands-on execution skills.
• Strong stakeholder management and collaboration across departments.
• Results-oriented mindset with attention to detail.
• Ability to work under pressure and meet strict compliance deadlines.
• Proven track record of driving process improvements and achieving audit success.

Ready to take your career to new heights?

We're InTalent Asia, your go-to recruitment partner in Sri Lanka, and we've got an exciting opportunity for you! Our client is looking for a dynamic individual to fill the role of Quality & Regulatory Manager.

At InTalent Asia, we're not just recruiters; we're here to architect your career success. Join us in the journey of matching your skills with unparalleled opportunities.

Apply now and see how you can be the perfect fit for this exclusive position!

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