Executive search firm Monroe Consulting Group is recruiting a RAQA Specialist on behalf of a multinational medical device company. The role will be responsible in creating and executing regulatory strategies for Asia/Pacific registrations and participates in any resultant compliance activities. Role will report to a Regional Lead and will be based in PH office (Quezon City) with hybrid working setup.
- Participate and coordinate in the development and reviews of regulatory strategies, in conjunction with the needs of the company, for each product range and change. 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 and cross functional teams/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 prior submission to ensure the documents meet and/or fulfill the country requirement/request. Ensure the documents are legalized and/or notarized where required.
- Monitor and update registration activities and/or status to all relevant stakeholders in 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.
- Ensure timely approval of registration in targeted markets.
- Manage changes to licenses due to product/manufacturing related changes to minimize or prevent risk/impact to business. Ensure proper processes are in-place to ensure effective management of changes with consideration of inventories cut in in accordance with license approval.
- Monitor license expiry and establish routine follow up with the affected countries to ensure license renewal to be conducted in a timely manners.
- Participates and supports team in business interactions and negotiations with regulatory agencies on submission requirements, labeling claims, etc.
- Ensure on time reporting of adverse events to authority. 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.
- Maintain quality system/GDP procedures and support on-site audits for Malaysia establishment
- Establish, maintain, and improve commercial quality management systems in SEA+ countries (Malaysia, Singapore, Thailand and Philippines, & support for Indonesia) whenever applicable. Lead internal and external audits.
- Cross functional collaboration to create and update SOPs/work instructions. Help to manage QMS training across the commercial teams. Manage audit findings, NC and CAPAs, and report to management at management review and KPI reporting.
- Bachelor's degree in Pharmacy or other related Science Discipline
- 3 years combined experience in regulatory affairs and quality assurance experience from medical device industry; preferably with experience in regional markets
- Individuals who have obtained a Regulatory Certification are a plus.
- Detail oriented, with emphasis on accuracy and completeness
- Effective written and oral (English) communication skills
- 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
- Computer literacy (PC, Microsoft Word/Excel/PowerPoint