Regulatory Specialist Medical Device

Flexicare Group; Kuala Lumpur; On-site; MYR 70,000 - 100,000; Full time

Job summary

A healthcare solutions provider is looking for a Regulatory Affairs professional based in Kuala Lumpur. You will manage submissions, certifications, and compliance for medical devices across the APAC region, collaborating with various teams and ensuring adherence to standards. The ideal candidate should have a Bachelor's in Science, 2-3 years of experience in Regulatory Affairs, and exceptional communication skills. This position requires flexibility in working hours for coordination with the UK office.

Qualifications

• Minimum 2 - 3 years work experience in Regulatory Affairs for medical device products.
• Excellent verbal and written communication skills with strong English language proficiency.
• Comprehensive understanding of regulatory activities.

Responsibilities

• Support submissions of registrations, licenses, and renewals in APAC region.
• Compile and review technical file for EU MDR to obtain/maintain CE marking.
• Collaborate with cross-functional teams to ensure regulatory compliance.

Skills

Regulatory Affairs experience

Communication skills

Attention to detail

Problem-solving

Knowledge of ISO standards

Team collaboration

Education

Bachelor's Degree in Science

Tools

Microsoft Office

Windows

Job description

Overview

Keeping up-to-date with the Company's product range. Supporting submissions of registrations, licenses and renewals in APAC region (including Japan) to strict deadlines ensuring the product certification matches product code/scope. Compile and review technical file for EU MDR to obtain/maintain CE marking. Assist in tracking standards, regulations and all applicable requirements, and feedback to the management. Assist in interactions regarding regulatory affairs with all functional areas of the company as required. Stay updated on new and existing regulations, guidance documents, and standards, and communicate their impact on products and business to clients and internal teams. Support in specifying labelling and packaging requirements for compliance with US, EU, International submissions and applicable regulations. Work closely with the Notified Body to approve Change Notifications for medical devices. Participate in company regulatory and quality audits when required. Collaborate with cross-functional teams to ensure regulatory compliance at all stages of the product lifecycle. As and when requested carryout other regulatory tasks delegated by the manager.

Responsibilities

• Keeping up-to-date with the Company's product range.
• Supporting submissions of registrations, licenses and renewals in APAC region (including Japan) to strict deadlines ensuring the product certification matches product code/scope.
• Compile and review technical file for EU MDR to obtain/maintain CE marking.
• Assist in tracking standards, regulations and all applicable requirements, and feedback to the management.
• Assist in interactions regarding regulatory affairs with all functional areas of the company as required.
• Stay updated on new and existing regulations, guidance documents, and standards, and communicate their impact on products and business to clients and internal teams.
• Support in specifying labelling and packaging requirements for compliance with US, EU, International submissions and applicable regulations.
• Work closely with the Notified Body to approve Change Notifications for medical devices.
• Participate in company regulatory and quality audits when required.
• Collaborate with cross-functional teams to ensure regulatory compliance at all stages of the product lifecycle.
• As and when requested carryout other regulatory tasks delegated by the manager.

Requirements

• Minimum 2 - 3 years work experience in Regulatory Affairs for medical device products
• Possess at least a Bachelor’s Degree in Science from an accredited university
• Excellent verbal and written communication skills with strong English language proficiency. Knowledge of additional languages (e.g., Korean, Japanese, Mandarin) is highly desirable and will be considered an advantage.
• Extensive knowledge of quality management system, ISO13485, 21CFR820, MDD93/42/EEC, MDR, MDSAP and applicable standards issued by the International Standards Organization (ISO).
• Strong computer skills required (including but not limited to Windows and Ms Office).
• Exceptional ability to work independently with minimal supervision, effectively organise, priorities and manage multiple projects
• Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work-related issues.
• Positive attitude, strong attention to detail and ability to solve problems independently
• Comprehensive understanding of regulatory activities and how they impact other products and/or processes
• Based in KL office, willing to exhibit flexibility in working hours to cater for the communications with the UK office.
• Open to non-Malaysians with a valid work permit or permanent resident (PR) status.

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