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Regulatory Affairs Specialist

2 months ago

Singapore IDEALS RECRUITMENT PTE. LTD. Full time

IDEALS RECRUITMENT PTE. LTD. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring our products and processes meet ISO standards and regulatory requirements. Your expertise in quality assurance and compliance will be instrumental in leading internal and external audits, managing regulatory document submissions, and working closely with regulatory agencies to ensure compliance. If you have a strong attention to detail, excellent organizational skills, and a passion for regulatory affairs, we encourage you to apply. Key Responsibilities:

* Ensure products and processes meet ISO standards and regulatory requirements.
* Lead internal and external audits and follow up on corrective actions.
* Manage the submission of regulatory documents for Singapore, Vietnam, and Thailand.
* Work closely with regulatory agencies to ensure compliance.
* Provide training on quality processes and support teams.

Requirements:

* Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field.
* 3-5 years of experience in QA and RA, ideally in medical devices.
* Knowledge of ISO 13485, ISO 9001, and local regulatory requirements.
* Strong attention to detail and good organizational skills.

Why IDEALS RECRUITMENT PTE. LTD.?

* Be part of a world leader in diagnostic imaging.
* Work in a friendly, supportive team with growth opportunities.

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply. Only shortlisted candidates will be notified.