Job Description

Job Summary: The Regulatory Affairs Specialist assists in carry out the regulatory operations to ensure on time submission and approval in line with product launches strategy in SEA. The RAQA Specialist is also providing support to maintain the local Quality Management System (QMS) in compliance with the corporate global and local regulatory requirements (if any).

CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.

At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and a diverse, inclusive, employee-centric culture fuel a deeply engaged, high performing organization.

CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That\xe2\x80\x99s a strong reflection of our corporate culture\xe2\x80\x94and part of the reason CooperVision may be a great workplace for you.



Knowledge, Skills and Abilities:

• Excellent organization skills
• Excellent attention to detail.
• Excellent written and verbal communication skills in English. Able to converse in any SEA (e.g. Thai, Vietnamese, Indonesian, Filipino) language will be an added advantage.
• Experience in registration submission in Malaysia/Singapore
• 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 general supervision.

Experience:
1-2 years of medical device regulatory submission Education:
Bachelor\xe2\x80\x99s degree in a scientific or technical discipline and working knowledge of medical device regulations. Work Environment:

• Office Environment
• Prolonged use of Computer
• Light lifting and bending

Essential Functions: Product registration, change / amendment, renewal

• Support regulatory functions through preparation and compiling of regulatory documents for new registration submission to health authorities.
• Support the product licenses maintenance.
• Regular check on the regulatory submission status on the health authority official website and with distributors/consultants.
• Filling of all related registration documents.
• Support the review of product labelling, IFU and promotional material to ensure compliance with corporate global and local regulatory requirements.

Post Market Vigilance - Complaint, Adverse Event (AE), Field Safety Corrective Action (FSCA), Recall

• Support in addressing product complaint from customer to manufacturer, monitor the status until closure.
• Assist to report Adverse Event (AE) to Global RA team.
• Assist to report the vigilance activities to health authorities based on the regulation in relevant countries.

Quality Assurance

• Support to maintain the local Quality Management System (QMS) in compliance with the corporate global and local requirements.
• Assist to perform internal audits to support compliance with applicable corporate global and local requirements.

Others

• Prepare and submit regulatory report on a regular/monthly basis.
• Updating Global RAQA Database
• Any RAQA related tasks and/or projects assigned.

CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.

At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and a diverse, inclusive, employee-centric culture fuel a deeply engaged, high performing organization.

CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That\xe2\x80\x99s a strong reflection of our corporate culture\xe2\x80\x94and part of the reason CooperVision may be a great workplace for you.