Ra & QA Manager
5 months ago
Main Purpose of the Role
**Responsibilities**:
1. Regulatory Affairs:
Communicate and align with commercial and marketing lead, and other stakeholders on the registration plan and strategy, and timely update on the status as well as the actions taken to address any delay or potential delay.
Coordinate, compile, submit and process regulatory submissions for both new product and renewal registrations.
Ensure timely execution of regulatory strategies as per business plan.
Communicate with Health Authority for enquiries regarding the registration.
Track regulatory milestones in internal Regulatory database.
Maintain up-to-date knowledge of regulatory requirements throughout the product life-cycle.
Ensure timely reporting of Adverse Events and Field Corrective Actions as per local regulation.
Perform regulatory assessments for EU MDR and/or RA Change Record and coordinate with manufacturing sites to prepare submission dossier.
Escalate any major/critical and urgent regulatory compliance issue in timely manner, whenever applicable.
2. Quality Assurance:
Develop, implement, and maintain quality systems, including Standard Operating Procedures (SOPs), to ensure compliance with regulations and standards.
Conduct internal and external audits to assess compliance and identify areas for improvement.
Establish and monitor key performance indicators (KPIs) related to quality and regulatory performance for ISO 13485, and other applicable guidelines.
Manage CAPA, change controls, NC and stop shipment as per requirements.
Working together with function leaders, set up training matrix for all the quality related training, and review periodically; Provide Quality training, including but not limited to Quality SOPs/WIs.
3. Training and Documentation:
Provide training to employees on quality and regulatory requirements.
Maintain accurate and organized documentation related to quality and regulatory activities.
4. Continuous Improvement:
Drive continuous improvement initiatives to enhance quality systems, processes, and overall compliance.
Stay updated on industry trends, changes in regulations, and best practices in quality assurance and regulatory affairs.
Qualification
A minimum 5 years RA and QA experience in the medical device industry.
Strong understanding of Thai FDA regulations, ISO 13485, and other relevant standards. Experience with regulatory submissions in Thailand.
Proven track record of implementing and maintaining quality system.
Strong knowledge and experience in the Cold Chain quality management.
Excellent communication and interpersonal skills to collaborate with cross-functional teams and regulatory agencies>
Attention to detail, analytical thinking, and problem-solving abilities.
Certifications such as Certified Quality Auditor (CQA) or Regulatory Affairs Certification (RAC) is a plus.
Proficiency in relevant software tools for documentation, data analysis, and quality management.
Able to communicate clearly and persuasively, with a focus on timely, open and honest communication, while being open to feedback.
Strong leadership skills and project management skills in building and guiding teams through development and maintenance of ISO13485
Comfort with adapting and adjusting to multiple demands, shifting priorities, ambiguity, and rapid change, yet being able to take ownership of projects from planning through to execution
Good command in English
Soft Skills
Excellent in active listening, probing and getting to the core needs of an internal customer.
Persuasive and affable, being able to influence rather than to order.
Seeing colleagues and other functions as customers and practising customer centricity.
Bottom-up view of initiatives instead of top-down high-level views only.
Able to draw up measurable objectives and logical processes to drive toward achieving them.
Meticulous, calm, detail oriented, logical, objective and collaborative in professional setting.
Willing to speak up and justify requests based on needs of business unit team.
Excellent training skills, being able to train internal customers in an interactive, supportive, memorable and highly motivational manner.
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