Regulatory Affair Specialist

An exciting opportunity has arisen for a Regulatory Affairs Specialist to join a reputable organisation in Kuala Lumpur, supporting both Malaysia and Singapore operations. This role is perfect for someone who is passionate about ensuring regulatory compliance within the medical device sector and is eager to make a meaningful impact on patient safety and product quality. You will be part of a supportive team that values collaboration, knowledge sharing, and professional growth.

As a Regulatory Affairs Specialist, your day-to-day responsibilities will involve :

• Support the Regulatory Affairs Manager in preparing and submitting regulatory documents for medical devices in Malaysia and Singapore, ensuring timely approvals.
• Assist with the full life-cycle management of medical device registrations, including handling variations and renewals according to local regulations.
• Contribute to quality-related functions such as updating work instructions, coordinating product recalls, and managing Corrective and Preventive Action Requests (CAPA).
• Maintain accurate quality documentation and Standard Operating Procedures (SOPs) to ensure ongoing GDPMD compliance within Malaysia.
• Review promotional materials to confirm alignment with both local regulatory requirements and internal company policies before approval.
• Perform vigilance activities by conducting reportability assessments and other related tasks as required by regulatory authorities.
• Approve medical device labels or artwork for production after thorough review against applicable standards.
• Approve promotional materials following detailed evaluation of their compliance with relevant guidelines.
• Collaborate effectively with internal teams such as commercial, supply chain, global packaging groups, regional regulatory affairs teams, consultants, distributors, and government agencies.
• Engage proactively with external stakeholders including medical/regulatory authorities to facilitate smooth communication and address any compliance issues.

The ideal candidate for the Regulatory Affairs Specialist position should include:

• Hold a bachelor's degree in science or life sciences from a recognised institution which provides you with a solid foundation in technical concepts relevant to regulatory affairs.
• Possess 1-3 years of hands-on experience in registering medical devices with the Medical Device Authority (MDA) in Malaysia which demonstrates your familiarity with local processes.
• Experience working on regulatory affairs matters involving the Singapore Health Sciences Authority (HSA) would be considered an added advantage for this position.
• Demonstrate strong project management skills that enable you to prioritise multiple projects efficiently while meeting tight deadlines under pressure.
• Showcase excellent organisational abilities that help you maintain meticulous records of documentation required for audits or inspections.
• Display effective interpersonal skills allowing you to interact professionally with internal client teams as well as manufacturing site personnel.
• Be familiar with current regulatory environments including an understanding of labelling regulations and controls specific to medical devices.
• Exhibit flexibility in adapting quickly to changing priorities or urgent requests from stakeholders without compromising on accuracy or quality.
• Have proven ability to collaborate within cross-functional teams spanning commercial operations, supply chain management, global packaging groups, regional RA teams, consultants/distributors, and government agencies.

Desired Skills and Experience
As a Regulatory Affairs Specialist, your day-to-day responsibilities will involve :

1) Support the Regulatory Affairs Manager in preparing and submitting regulatory documents for medical devices in Malaysia and Singapore, ensuring timely approvals.

2) Assist with the full life-cycle management of medical device registrations, including handling variations and renewals according to local regulations.

3) Contribute to quality-related functions such as updating work instructions, coordinating product recalls, and managing Corrective and Preventive Action Requests (CAPA).

4) Maintain accurate quality documentation and Standard Operating Procedures (SOPs) to ensure ongoing GDPMD compliance within Malaysia.

5) Review promotional materials to confirm alignment with both local regulatory requirements and internal company policies before approval.

6) Perform vigilance activities by conducting reportability assessments and other related tasks as required by regulatory authorities.

7) Approve medical device labels or artwork for production after thorough review against applicable standards.

8) Approve promotional materials following detailed evaluation of their compliance with relevant guidelines.

9) Collaborate effectively with internal teams such as commercial, supply chain, global packaging groups, regional regulatory affairs teams, consultants, distributors, and government agencies.

10) Engage proactively with external stakeholders including medical/regulatory authorities to facilitate smooth communication and address any compliance issues.

The ideal candidate for the Regulatory Affairs Specialist position should include:

1) Hold a bachelor's degree in science or life sciences from a recognised institution which provides you with a solid foundation in technical concepts relevant to regulatory affairs.

2) Possess 1-3 years of hands-on experience in registering medical devices with the Medical Device Authority (MDA) in Malaysia which demonstrates your familiarity with local processes.

3) Experience working on regulatory affairs matters involving the Singapore Health Sciences Authority (HSA) would be considered an added advantage for this position.

4) Demonstrate strong project management skills that enable you to prioritise multiple projects efficiently while meeting tight deadlines under pressure.

5) Showcase excellent organisational abilities that help you maintain meticulous records of documentation required for audits or inspections.

6) Display effective interpersonal skills allowing you to interact professionally with internal client teams as well as manufacturing site personnel.

7) Be familiar with current regulatory environments including an understanding of labelling regulations and controls specific to medical devices.

8) Exhibit flexibility in adapting quickly to changing priorities or urgent requests from stakeholders without compromising on accuracy or quality.

9) Have proven ability to collaborate within cross-functional teams spanning commercial operations, supply chain management, global packaging groups, regional RA teams, consultants/distributors, and government agencies.

Robert Walters SEA is acting as an Employment Business in relation to this vacancy.