Regulatory & Quality Assurance Specialist

Leonix Sdn Bhd; Bayan Lepas; On-site; MYR 78,000 - 123,000; Full time

Job summary

Leonix Sdn Bhd is seeking a Regulatory Affairs professional in Penang to ensure compliance with ISO 13485 and GMP, manage regulatory documentation, and support product lifecycle regulatory needs. Responsibilities include post-market surveillance, risk assessment, and collaboration across R&D, QA, clinical affairs and marketing.

The role also involves audits, training internal stakeholders, and staying abreast of global regulatory changes impacting medical devices in the region.

Responsibilities

• Ensure compliance with quality management systems and standards such as ISO 13485 and GMP.
• Perform the 'buy off' process as part of the quality assurance scope.
• Monitor process technicians for proper procedure compliance.
• Perform Biomechanical, Product Failure and Reject Analysis tests.
• Inspect incoming raw materials from vendors and report deficiencies.
• Analyze deficient products and determine the root cause.
• Ensure compliance with applicable regulations, laws and guidelines in relevant jurisdictions.
• Develop and maintain regulatory documentation, including registrations, submissions and dossiers.
• Collaborate with cross-functional teams to develop regulatory strategies, including product approvals, licensing and post-market surveillance.
• Conduct risk assessments and provide mitigation recommendations.
• Stay up-to-date with regulatory developments in the medical devices sector and communicate impacts to stakeholders.
• Collaborate with R&D, QA, Clinical Affairs and Marketing to meet regulatory requirements throughout the product lifecycle.
• Assist in internal and external audits and inspections and address findings.
• Provide regulatory training and guidance to internal stakeholders.

Job description

Leonix Sdn Bhd is seeking a Regulatory Affairs professional in Penang to ensure compliance with ISO 13485 and GMP, manage regulatory documentation, and support product lifecycle regulatory needs. Responsibilities include post-market surveillance, risk assessment, and collaboration across R&D, QA, clinical affairs and marketing.

The role also involves audits, training internal stakeholders, and staying abreast of global regulatory changes impacting medical devices in the region.