Regulatory Affairs Officer

Getz Healthcare (M) Sdn. Bhd.; Kuala Lumpur; Hybrid; MYR 100,000 - 150,000; Full time

Job summary

Getz Healthcare is seeking a Regulatory Affairs Officer to manage product registration processes and ensure compliance across Hong Kong and Singapore. The ideal candidate will have a Bachelor's degree and at least 2 years of experience in regulatory affairs in the healthcare or medical device industry. The role includes significant collaboration with internal teams and external regulatory bodies, focusing on accurate documentation and compliance with evolving regulations. This position offers a hybrid work environment, adapting to regulatory demands while working alongside international teams.

Qualifications

• Minimum of 2 years of combined experience in Regulatory Affairs.
• Strong proficiency in written and spoken English.
• Familiarity with regulatory frameworks.

Responsibilities

• Ensuring compliance with local and international regulatory requirements.
• Preparing, submitting, and managing regulatory filings.
• Communicating with regulatory authorities to obtain approvals.

Skills

Communication

Attention to detail

Analytical thinking

Problem-solving

Adaptability

Education

Bachelor’s degree in medical, science or business-related discipline

Tools

AI tools

SharePoint

Regulatory databases

Job description

Application Link : https://getzhealthcare.bamboohr.com/careers/239?source=aWQ9MzI%3D

Job Duration: 1 year contract

JOB PURPOSE

The Regulatory Affairs Officer is responsible for supporting the product registration process primarily within Hong Kong and Singapore, ensuring compliance with regulatory requirements and facilitating timely approvals. This role involves coordinating with various external parties such as regulatory authorities, third party agents, business partners, and conformity assessment bodies (CAB); preparing and submitting documentation, and collaborating with internal teams to ensure adherence to local and international regulations.

By maintaining up-to-date knowledge of regulatory changes, the Regulatory Affairs Officer plays a key role in ensuring product approval with the health authorities.

DUTIES AND RESPONSIBILITIES

Ensuring compliance with local and international regulatory requirements for products and services.

Communicating with business partners to gather documents required for product registration within the required time frame.

Reviewing and analyzing business partner’s documents, using a number of different methods including artificial intelligence (AI), for product registration in compliance with applicable regulations.

Preparing, submitting, and managing regulatory filings, including applications, renewals, and changes.

Collaborating with cross-functional teams and external agencies to ensure products meet legal, industry and quality management standards.

Monitoring and interpreting changes in regulations to advise the company on necessary adjustments.

Communicating with regulatory authorities and third-party agents to obtain approvals, resolve issues, and maintain compliance.

Maintaining accurate documentation and records to support audits and inspections.

Providing guidance and training to teams on regulatory requirements and best practices.

Addressing regulatory inquiries and supporting risk management initiatives.

WORKING CONDITIONS

The Regulatory Affairs Officer will work in a hybrid environment, splitting time between remote work and in-office duties, as determined by your manager. The individual will be based in Malaysia and will collaborate with local and international teams.

SKILLS & QUALIFICATIONS

Education: Bachelor’s degree in medical, science or business-related discipline.

Experience: Minimum of 2 years of combined experience in Regulatory Affairs, preferably with exposure to the healthcare or medical device industry.

Skills:
1. Strong proficiency in both written and spoken English, with excellent communication skills for liaising with internal and external stakeholders.

2.Highly detail-oriented with an analytical mindset, ensuring accuracy in regulatory documentation and compliance assessments.
3.Well-organized and capable of managing multiple regulatory processes efficiently.
4.Proactive in problem-solving, with the ability to assess risks and determine appropriate solutions.
5.Adaptability to evolving regulatory requirements and the ability to work in a fast-paced environment.
6.Familiarity with relevant regulatory frameworks and digital tools e.g. AI, SharePoint, etc. for documentation management.
7.Handling electronic submissions and regulatory databases.

Business Understanding: Strong knowledge of licensing and product registration processes and overall regulatory compliance

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Which of the following statements best describes your right to work in Malaysia? What's your expected monthly basic salary? Which of the following types of qualifications do you have? How many years' experience do you have as a Regulatory Affairs Officer? Which of the following languages are you fluent in?

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