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?#J-18808-Ljbffr