RAQA Specialist

Overall Responsibilities

The RAQA Specialist will be responsible for regulatory and quality projects and improvements to meet company goals. This includes ensuring compliance to Regulatory Affairs (RA), Quality Systems (QS) and Quality Assurance (QA) requirements in SEA markets for Applied Medical products by performing premarket and post-market activities. The specialist must be capable of working within a team environment, striving to meet or exceed customer expectations.

Essential Duties

• Obtain product registration approvals from relevant authorities according to organization's

regulatory plan and strategy in SEA by compiling dossier as per local medical device regulations and collaborating closely with Headquarter Premarket team and authorities/distributors.

• Assess changes and its impact on registrations for changes initiated by Product Owner and communicate impact to relevant stakeholders.
• Prepare, submit, and obtain approvals in a timely manner for changes initiated by Product Owner for continued market access.
• Timely renewal of product registrations.
• Monitor, prepare, and support compliance to adverse events reports, recalls and other required post-market surveillance regulations.
• Participate in internal and external audits as required.
• Support the implementation and compliance of Quality Management System in Singapore.
• Keep abreast with changes in the regulatory environment in SEA.
• Perform additional duties and responsibilities as required by leadership.

Other Duties And Responsibilities

• Seek to understand multiple pathways to compliance and incorporate all perspectives in creating solutions and decision making.
• Build necessary relationships with internal and external stakeholders.
• Support the Field Implementation team with relevant documents for tender submissions.
• Identify and implement systems to improve the overall efficiency of processes.
• Perform additional duties and responsibilities as required by leadership.

Position Qualifications

Knowledge, skills, and abilities

• Preferably experienced working with Thai FDA
• Effective in obtaining and maintaining Marketing Authorizations or Registrations for medical devices, including handling change management.
• Experience in performing post-market activities, such as adverse event reporting and handling of recalls.
• Competent in supporting QMS on-site and document audits.
• Preferred knowledge in ISO 13485, ISO 14971, ISO 60601, GDP.
• Familiarity with supplier control and experience working with 3PL and/or 4PL.
• Ability to work independently and as part of a team.
• Able to multi-task, organize and prioritize.
• Analytical, meticulous and detail oriented.
• Assertive and not afraid to ask questions.
• Friendly, good attitude, customer service oriented.
• Effective oral and written communication and presentation skills in English.