Regulatory Affair Senior Executive

PCCS Group Berhad; Kuala Lumpur; On-site; MYR 200,000 - 250,000; Full time

Job summary

A leading Medical Device company in Kuala Lumpur seeks a Regulatory Affairs Executive to manage regulatory submissions, maintain compliance documentation, and support training sessions. The ideal candidate holds a Bachelor's Degree in Biomedical Science or related field, has 2-5 years of regulatory experience, and is proficient in Microsoft Office. Strong analytical skills and Mandarin proficiency are required for effective communication with partners. This role offers an opportunity to work in a dynamic regulatory environment.

Qualifications

• Minimum 2–5 years of experience in regulatory affairs in medical devices.
• Strong analytical and problem-solving skills.
• Mandarin speaking required for liaising with partners.

Responsibilities

• Oversee regulatory submissions ensuring compliance.
• Prepare and maintain regulatory documentation.
• Support training sessions related to regulatory topics.

Skills

Regulatory affairs experience

Proficient in Microsoft Office

Analytical skills

Team player

Communication skills

Education

Bachelor’s Degree in Biomedical Science or related field

Job description

Execute and oversee regulatory submissions to ensure timely processing and compliance.

Maintain proactive communication and good working relationships with regulatory authorities.

Prepare, review, and maintain regulatory documentation and product registration files.

Assist in the development, implementation, and maintenance of SOPs and other regulatory documents.

Review promotional and marketing materials to ensure compliance with applicable regulations and company guidelines.

Support regulatory strategy planning and contribute to continuous improvement initiatives.

Maintain Good Distribution Practice for Medical Devices (GDPMD) compliance and support ISO-related activities.

Participate and assist during internal and external audits when required.

Execute day-to-day regulatory activities, monitor submission progress, and update relevant stakeholders.

Support training sessions and presentations for internal and external meetings related to regulatory topics.

Collaborate cross-functionally with other departments to ensure alignment with regulatory requirements.

Ensure proper documentation, tracking, and archiving of regulatory submissions and correspondence.

Requirements

Bachelor’s Degree in Biomedical Science, Life Sciences, Pharmacy, or a related field.

Minimum 2–5 years of experience in regulatory affairs within the medical device or pharmaceutical industry.

Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Good oral and written communication skills in English (additional languages an advantage).

Strong analytical and problem-solving skills; able to think critically and resolve issues independently.

Result-oriented, reliable, and able to perform well under pressure.

Independent yet a strong team player with a continuous improvement mindset.

Trustworthy, resourceful, and demonstrates initiative in completing tasks.

Willing to learn and adhere to company processes and regulatory requirements.

Able to conduct or assist in training and presentations for internal/external stakeholders.

Mandarin speaking required as need to liaise with Mandarin speakingbusiness partner.

Remark

Candidates with more extensive regulatory experience (typically 5 years or more) and proven leadership capabilities may be considered for the Assistant Manager (Regulatory Affairs) position, with expanded responsibilities in strategy development, team supervision, and regulatory project leadership.

Unlock job insights

Your application will include the following questions:

• What's your expected monthly basic salary?
• How many years' experience do you have as a Regulatory Affairs Executive?
• Which of the following Microsoft Office products are you experienced with?
• How would you rate your Mandarin language skills?
• Which of the following languages are you fluent in?
• How much notice are you required to give your current employer?