Manager, RAQA

Position

Manager, RAQA (SEA)

Teleflex is seeking a Manager, RAQA (SEA) to join our Regulatory Affairs and Quality Assurance team. This role requires creating and executing regulatory strategies for Southeast Asia (SEA+) registrations and participating in related compliance activities. The incumbent coordinates and implements strategies to ensure products comply with regulatory requirements prior to distribution, maintains ongoing interactions with regulatory bodies in SEA+, and uses foresight and analytical skills to address challenging problems. The role includes supervising and training less experienced regulatory personnel and providing input to management on new or changing regulations domestic and abroad.

Expected Travel: Up to 10%

Requisition ID: 12686

Principal Responsibilities

• Participate and coordinate in the development of regulatory strategies for each product range and change, establishing regular reviews with Sales & Marketing and other stakeholders to align with company needs and marketing strategy. Identify risks or changes to strategies and involve relevant stakeholders for action planning.
• Liaise with country RA, registration agents, distributors, sales & marketing and other stakeholders to understand and evaluate registration requirements for designated markets.
• Develop timelines, coordinate collection of technical information, and manage the preparation of submissions for new products, amendments/variations, and maintenance of existing licenses. Review documents to ensure they meet country requirements and ensure legalization/notarization where required.
• Develop timelines and coordinate responses to regulatory agency questions or requests for information.
• Monitor and update registration activities and statuses to stakeholders; ensure required actions are in place and report delays with action plans as needed.
• Monitor license expiry and follow up with affected countries to renew licenses timely.
• Participate and assist in promotional materials review, data analysis, risk management, and product labeling related to registration and commercialization in the SEA region.
• Coordinate labeling artwork and Instructions For Use (IFU) preparation, including translations to required languages; review and approve activities for new or modified products.
• Ensure compliance with relevant country medical device regulatory and registration requirements; monitor laws and regulations and communicate updates to RA management.
• Review product development documentation to ensure data collection supports regulatory submissions and compliance, using appropriate standards, experimental designs, evaluation criteria, and statistical rationale per regional guidelines.
• Participate in business interactions and negotiations with regulatory agencies on submission requirements and labeling claims.
• Escalate Regulatory Affairs questions/issues to RA/QA management.
• Participate in other tasks and projects as assigned by the supervisor.
• Review complaints for potential adverse events and ensure reports are submitted to the appropriate agencies in accordance with procedures and regulations.
• Support QMS compliance and QA tasks, including product complaint handling, adverse event reports, field corrective actions, nonconformances, internal/external audits, document change control, and maintenance of regulatory databases.

Education / Experience Requirements

• A minimum of a Diploma/Bachelor's degree
• A minimum of 6–10 years regulatory experience in the medical device industry for the SEA+ region
• Computer literacy (PC, Microsoft Word/Excel/PowerPoint)

Specialized Skills / Other Requirements

• The ideal candidate would have a diploma/degree in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology
• Regulatory Certification is a plus
• Previous experience working for a medical device manufacturer or distributor

Behaviours And Values

• Detail-oriented, with emphasis on accuracy and completeness
• Effective written and oral communication skills
• Effective leadership and team motivation
• Good organizational and planning skills; drives for results
• Effective analytical/problem-solving skills
• Good interpersonal skills with ability to lead others
• Ability to exercise independent judgment within defined policies and practices
• Ability to handle multiple tasks and prioritize work to meet business needs with routine supervision

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.

Teleflex is an equal opportunities employer.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or third-party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

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