Manager, RAQA (SEA)

Position Summary

The Assistant Manager, RAQA creates and executes regulatory strategies for Southeast Asia (SEA+) registrations and participates in any resultant compliance activities. The incumbent coordinates and implements regulatory strategies to ensure products comply with all relevant regulatory requirements prior to distribution. He/she is responsible for continued interaction between the company and the various regulatory bodies in SEA+ and work on difficult problems requiring exercise of foresight and analytical skills. In addition, he/she shall exercise independent judgement and discretion within a broadly defined range of policy and practice. The incumbent supervises and trains less experienced regulatory personnel and ensures performance. He/she assists the RA Head in the interpretation of statutes and regulations for the business; communicate how these will impact all aspects of product development, manufacture and marketing. He/she shall provide input and advise management on new or changing regulations both domestic and abroad and evaluates the regulatory impact of changes associated with product design change and routine change control.

Principal Responsibilities

• Participate and coordinate in the development of regulatory strategies, in conjunction with the needs of the company, for each product range and change. Establish regular review with Sales & Marketing and other relevant stakeholders to ensure the strategies are in alignment with company needs and marketing strategy. Identify risks and/or changes to the strategies (if any) and involve the relevant stakeholders for discussion on action plan.
• Liaise with the necessary parties, country RA, registration agents, distributors, sales & marketing and other relevant stakeholders, to understand and evaluate the requirements for product registrations for designated market.
• Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of submissions for new products, amendment/variation of approved products and submissions that support the maintenance of existing licenses. Review the technical documents obtained from different sources before submission to external party and/or authority to ensure the documents meet and/or fulfill the country requirement/request. Ensure the documents are legalized and/or notarized where required.
• Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information.
• Monitor and update registration activities and/or status to all relevant stakeholders in a regular basis. Ensure the required actions and responses are in place in a timely manner. Identify and report any delay to the registration timeline and involve the relevant stakeholders for discussion on action plan.
• Monitor license expiry and establish routine follow-up with the affected countries to ensure license renewal be conducted in a timely manner.
• Participate and assist in promotional materials review, data analysis, risk management and product labeling as they relate to registration and commercialization of medical devices in the SEA region.
• Participate and coordinate in the labeling artwork and Instructions For Use (IFU) preparation (include translations to the required foreign languages), review and approve activities for new and/or modified products.
• Ensure compliance with the relevant country medical device regulatory and/or product registration requirements. Monitor government agency laws and regulations throughout websites/publications, or communicate with country RA for the latest updates. Obtain the correct interpretations of the requirements and bring it to the attention to RA management.
• Reviews product development documentation and/or other relevant information to assure collection of appropriate data for regulatory submissions and regulatory compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale per regional guidelines. 
• Participates in business interactions and negotiations with regulatory agencies on submission requirements, formats, labeling claims, etc. 
• Brings Regulatory Affairs questions/issues to the attention of RA/QA management.
• Participate in any other tasks and/or projects that are being assigned by the immediate supervisor, as and when required.
• Reviews complaints for potential adverse events and that reports of adverse events are submitted to appropriate agencies in accordance with established procedure and domestic and international regulations and standards.
• supporting QMS compliance and QA tasks such as 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 medical device industry for 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
• Individuals who have obtained a Regulatory Certification are a plus
• Previous experience working for a medical device manufacturer or distributor

Behaviours and Values:

• Detail-orientated, 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 that include working well in a team environment and the ability to lead others
• Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices
• Ability to handle multiple tasks and to prioritize/ schedule work to meet business needs with routine supervision

Ability to identify areas of concern in moderately complex projects and manage change