Regulatory Specialist (APAC) - Medical Device

Flexicare Group; Kuala Lumpur; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading medical device company in Kuala Lumpur is seeking a Regulatory Specialist to manage submissions and ensure compliance with regulations in the APAC region. The ideal candidate must have 2-3 years of experience in Regulatory Affairs, a Bachelor's degree in Science, and excellent communication skills in English. Knowledge of ISO standards and multiple languages is a plus. This position offers the opportunity to work independently and help navigate complex regulatory requirements while collaborating with cross-functional teams.

Qualifications

• Minimum 2-3 years of experience in Regulatory Affairs for medical devices.
• Excellent verbal and written communication skills.
• Strong ability to manage multiple projects independently.
• Comprehensive understanding of regulatory activities.

Responsibilities

• Support submissions of registrations and licenses in APAC.
• Compile technical files for EU MDR to obtain CE marking.
• Collaborate with teams to ensure regulatory compliance.
• Stay updated on regulations and communicate impacts.

Skills

Regulatory Affairs experience

Strong English proficiency

Knowledge of multiple languages

ISO13485 knowledge

Computer skills

Attention to detail

Problem-solving ability

Education

Bachelor’s Degree in Science

Tools

Microsoft Office

Windows

Job description

Regulatory Specialist (APAC) - Medical Device

• Keeping up-to-date with the Company's product range.
• Supporting submissions of registrations, licenses and renewals in APAC region 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 carry out 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, prioritise 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.