Job Description

:This role will act on behalf of management representative to ensure the Quality Management System is implemented to align with the corporate global Quality Management System (QMS) and local regulatory requirements in SEA operations.Responsibilities:This position responsible in obtaining SEA in registration approvals on time in line with product launches strategy and ensuring QMS is maintain align with corporate global QMS and relevant local requirementsProduct approvals / registration / licenses in SEA countries

• Develop regulatory strategies and submit all required pre-market submission to health authorities for approvals.
• Keep abreast and ensure compliance with the regulatory requirements.
• Communicates changes on focus countries regulations, guidance documents and industry standards that impact business to local stakeholders and global RAQA team.
• Support as liaison with regulatory authorities, relevant industries association representative and applicable distributors.
• Maintenance of all related product licenses and obtain approvals for all related submissions for maintenance of business.
• Support new product launch and distribution within focus countries through regulatory speed to market initiatives and partnership with local stakeholders and relevant global team to ensure compliance in product placement in SEA countries.
• Support and collaborate with Global RA Labelling and Marketing in the review of product labelling, IFU and promotional material to ensure compliance with internal policies and relevant regulations in SEA countries.

• Develop and implement regulatory and qualities procedures to ensure consistence compliance with corporate global QMS and applicable requirement.
• Collect, report and collaborate with Global Regulatory Affairs and Quality Assurance on complaints investigations, adverse event reporting, product recall, field safety notice and corrective action as needed for focus countries.
• Perform internal audits to ensure compliance with applicable local health authorities and Global requirements.

• Prepare and submit regulatory report on a regular/monthly basis.
• Updating of Global RAQA Database and / or relevant tools on RAQA projects updates.
• Support in providing budget inputs for SEA.
• Any RAQA related tasks and/or projects assigned.

• Excellent attention to detail.
• Excellent organization skills.
• Excellent written and verbal communication skills in English. Able to converse in any SEA (eg Thai, Vietnamese & Filipino) language will be an added advantage.
• Experience in registration submission and quality assurance management especially on GDPMD.
• Computer literate, with intermediate skill in the use of Word, Excel and Outlook.
• Ability to work effectively either alone or as part of a team. Managing time effectively and completing tasks on time with minimal supervision.

• Office environment.
• Prolonged use of a computer.
• Light lifting and bending.

• 4-5 years of medical device regulatory submission

• Bachelor\'s degree in a scientific or technical discipline and working knowledge of medical device regulations.

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