Job Description
The RAQA Senior Specialist is responsible for obtaining SEA registration approvals on time in line with product launches strategy and ensuring QMS is maintained and aligned with corporate global QMS and relevant local requirements.
This individual will interact with internal stakeholders and external stakeholders (including but not limited to local Health Authorities, Certification Body, 3 rd Party Logistics, distributors, consultants) to support the RAQA department daily operation. He/She will act on behalf of management representative to ensure the Quality Management System is implemented in alignment with the corporate global Quality Management System (QMS) and local regulatory requirements in SEA operations.
Responsibilities
Product approvals / registration / licenses in SEA countries
- Develop regulatory strategies and submit all required pre-market submission to health authorities (or through distributors) for approvals.
- Maintenance of all related product licenses and obtain approvals for all related submissions for maintenance of business.
- Keep abreast and ensure compliance with the regulatory requirements in SEA. Monitor the evolving regulatory requirements and assess their impact on business operations and product compliance.
- Communicate change 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, distributors and external consultants.
- Support new product launch and distribution 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.
Quality Assurance role in SEA
- Develop and implement regulatory and qualities procedures to ensure consistence compliance with corporate global QMS and applicable standards/regulatory requirement.
- Manage quality system activities related to Corrective Action/Preventive Action, non-conformance, change control and deviation investigation.
- Ensure timely investigation, resolution, and closure of quality issues while driving continuous improvement initiatives.
- 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.
- Oversee qualification, monitoring, performance evaluation, and periodic auditing of distributors to ensure compliance with applicable quality and regulatory requirements.
- Manage quality oversight of Third-Party Logistics Providers (3PLs), including performance monitoring, deviation management, periodic quality audit.
- Perform internal audits to ensure compliance with applicable local regulatory requirements (i.e. Good Distribution Practice for Medical Devices) and Global requirements.
- Conduct audit on distributors ensuring compliance with the applicable local regulatory requirements and Global requirements.
- Support Management Review and External Audit activity to demonstrate compliance with the applicable requirements.
Others
- Prepare and submit regulatory report on a regular/monthly basis.
- Support in providing budget inputs for SEA.
- Any RAQA related tasks and/or projects assigned.
- Ensures relevant Global RA and Global QA systems are updated
- Supports the Asia Pacific RAQA Team as required including Japan, Korea, China, ANZ and other Cluster countries.
Qualifications
Travel:
5-10% per year
Knowledge, Skills, and Abilities:
- 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.
Work Environment:
- Office environment.
- Prolonged use of a computer.
- Light lifting and bending.
Experience:
- Minimum 5 years of in-depth and hands-on regulatory submission experience in the medical device industry.
- Proven collaboration with global counterparts for ensuring efficiency and collaboration in RAQA inititiatives.
- Ability to operate in a business-driven model providing quick, salient analysis and concrete action plans emphasis on understanding and anticipating business needs and interests and devising proactive approaches/responses.
- GDPMD internal and external audit experience in major SEA markets like Singapore and Malaysia
- Post-market surveillance experience on complaint handling, AE reporting and product Recall
- Quality oversight experience of a 3PL will be a plus
Education:
- Bachelor's degree in scientific or technical discipline and working knowledge of medical device regulations.
