Regulatory Affairs Executive

1. Compliance

• Ensure that all products comply with local and international regulations.
• Keep abreast of changes in regulatory laws and industry guidelines.

2. Documentation and Submission

• Prepare, review, and submit regulatory documentation for product registration and approvals.
• Manage the lifecycle of regulatory files, including renewals and amendments.

3. Liaison with Authorities / Consultant

• Serve as the primary contact with regulatory agencies.

4. Product Development Support

• Collaborate with R&D, QA, and marketing teams to ensure regulatory compliance in new product development.

5. Audits and Inspections

• Assist in preparing for regulatory audits and inspections.
• Ensure all records and processes are audit-ready at all times.

Job Requirement

• Minimum 2-5 years of experience in regulatory affairs, preferably in the medical devices industry.
• Strong understanding of regulatory requirements, such as ISO, FDA, or local regulatory bodies.
• Ability to manage multiple projects and deadlines effectively.
• Strong interpersonal skills to work with cross-functional teams and external stakeholders.
• Problem-solving mindset and proactive approach to regulatory challenges.
• Fluency in English; proficiency in additional languages is a plus if working with international regulations.
• Willingness to travel occasionally for regulatory meetings or inspections.

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Your application will include the following questions:

• 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 Executive?
• Which of the following languages are you fluent in?
• How would you rate your English language skills?
• Are you willing to travel for this role when required?