Regulatory Affairs Executive

Vital Healthcare Sdn Bhd; Kapar; On-site; MYR 40,000 - 60,000; Full time

Job summary

A healthcare company is seeking a Regulatory Affairs Executive in Kapar, Selangor. You will play a vital role in ensuring compliance with medical device regulations, managing product registrations, and liaising with regulatory authorities. Successful candidates will hold a relevant bachelor's degree and have at least 1 year of experience in regulatory affairs. We offer a supportive work environment with clear advancement paths and performance incentives.

Benefits

Clear career progression paths

Mentorship programs

Performance-based incentives

Qualifications

• Minimum 1 year of experience in a regulatory affairs role within the pharmaceuticals or medical devices industry.
• Excellent understanding of the regulatory landscape in Malaysia.
• Proficient in using regulatory submission software.

Responsibilities

• Ensure regulatory compliance of company products and review medical device documentation.
• Carry on product registration and system certification according to the company's plan.
• Communicate with relevant authorities on registration matters to ensure timely approval.

Skills

Regulatory compliance knowledge

Attention to detail

Communication skills

Problem-solving

Interpersonal skills

Education

Bachelor's degree in Biomedical, Medical Science, or equivalent

Tools

Microsoft Office suite

Regulatory submission software

Job description

Vital Healthcare Sdn Bhd is seeking a highly motivated and experienced Regulatory Affairs Executive to join our team in Kapar, Selangor. In this full-time position, you will play a crucial role in ensuring our medical device products comply with all relevant regulations and guidelines. This is an exciting opportunity to contribute to the strategic growth of our company and make a real impact within the healthcare industry.

What you'll be doing

• Ensure regulatory compliance of company products and review documentation of medical device standards of (MDA), European Union (CE), USA (FDA), and other regions.
• Carry on product registration, system certification, renewal of the certificate obtained, and application for replacement of the certificate according to the company's plan.
• Follow up on the registration and internal review of registration application information throughout the process, and submit the application information to complete the registration application and supplementary application-related work.
• Follow up on the product registration progress, communicate with the government and relevant industry departments on registration matters, coordinate and deal with problems in the registration process, and ensure that registration approval documents are obtained on time.
• Staying up-to-date with the latest regulatory requirements and guidelines in the medical devices industry.
• Liaising with regulatory authorities and other stakeholders to address queries and ensure timely approval of our products.
• Providing regulatory guidance and support to the product development and marketing teams.
• Participating in the development of regulatory strategies and policies to support the company's growth objectives.

What we're looking for

• A bachelor's degree in a relevant field, such as Biomedical, Medical Science, or equivalent.
• Minimum 1 year of experience in a regulatory affairs role within the pharmaceuticals or medical devices industry.
• Excellent understanding of the regulatory landscape in Malaysia, including the requirements of the Malaysian Medical Device Authority (MDA) and the CE regulations.
• Strong attention to detail and the ability to work accurately under pressure to meet tight deadlines.
• Excellent communication and interpersonal skills, with the ability to liaise effectively with internal and external stakeholders.
• Proficient in Microsoft Office suite and experience with regulatory submission software.
• A proactive, problem-solving mindset and the ability to work independently as well as part of a team.

What We Offer

• Clear career progression paths, mentorship programs, and internal promotions.
• Open communication, team‑building activities, and a supportive leadership approach.
• Performance‑based incentives, employee appreciation events, and achievement awards.