Regulatory Affairs and Sales Support Associate

2 weeks ago

Singapore Ajj Healthcare Management Pte. Ltd. Full time

About Us

AJJ Healthcare is the healthcare innovation implementation arm of AJJ Medtech Holdings Limited (SGX: 584). AJJ Medtech, together with AJJ Healthcare, is Singapore's leading integrated Medtech solutions provider, transforming healthcare through innovative medial devices and service/experience excellence. With a profound commitment to our mission 'All for the commitment to life' to enhancing healthcare delivery, we leverage cutting-edge digital, artificial intelligence, robotics, and turn-key supply-chain solutions to meet the dynamic needs of the healthcare sector.

As a trusted partner to public health institutions and leaders in healthcare technology, we are dedicated to improving patient outcomes and healthcare efficiency. Our team is at the heart of our success, composed of industry experts who share a common vision of transforming healthcare in Singapore and beyond.

Fair Practices

AJJ Medtech and its affiliated entities are dedicated to fostering a culture rooted in Diversity, Equality, and Inclusivity. We strive to create a workplace where every individual has equal access to opportunities and can contribute without bias. Embracing a wide range of experiences and viewpoints, we are committed to building a team that represents the varied communities we serve, driving innovation and excellence in the healthcare industry.

About the Role

You will be in a crucial role to ensure our turn-key supply-chain solutions align with rigorous government tender and Health Sciences Authority (HSA) registration requirements, thus facilitating seamless market access and compliance. Furthermore, your expertise and implementation will strengthen our strategic positioning by supporting sales teams in navigating complex regulatory landscapes, thereby ensuring our solutions meet the highest standards of quality and safety essential for long-term partnerships and customer trust. You will get to work with industry leaders and experts.

This position is designated as part of our Management Track, offering a structured path for career advancement towards leadership roles within the organization. Candidates who demonstrate exceptional performance, strategic acumen, and leadership potential will have the opportunity to progress through key managerial positions, contributing significantly to our strategic goals and operational excellence.

Join us in shaping the future of healthcare, where your talent and passion can make a meaningful impact in the lives of many.

Responsibilities:

  • Ensure Compliance with Government Tenders and HSA Requirements: Actively ensure all supply-chain solutions comply with necessary government tender specifications and Health Sciences Authority (HSA) registration requirements to facilitate seamless market access and maintain compliance. Provide guidance and support to sales teams to navigate complex regulatory environments, helping align solutions with regulatory standards for market entry and expansion.
  • Maintain High Standards of Quality: Oversee the implementation of quality standards within supply-chain solutions to exceed industry standards, building long-term partnerships and customer trust.
  • Tactical Execution of Tender Costing and Sample Preparation: Actively engage with sales teams to meticulously prepare tender costings and quotations, ensuring accuracy and adherence to internal guidelines for approval. Efficiently coordinate the tactical aspects of sample preparation and shipment, and communicate with internal departments to secure the necessary information, underpinning the organization's tactical approach to market engagement and operational excellence.
  • Collaboration with Industry Leaders and Experts: Engage with industry leaders to stay informed on trends, regulations, and best practices in healthcare, driving innovation in the organization's solutions.
  • Prepare and Maintain Regulatory Documents: Review, prepare, and submit product dossiers, including variations, for registration and notification submissions. Track submissions and completions to ensure compliance with regulatory authorities' requirements. Including but not limited to labelling and packaging of medical devices
  • Address Regulatory Issues: Attend to issues related to the sales and distribution of regulated products, compliance with Quality Management Systems (e.g., ISO 13485), local and regional regulations, GDPMDS standards, and company SOPs.
  • Meticulous Book keeping and Documentation: Maintain current product licenses and registration documents, and support audits to ensure proper bookkeeping and compliance.

Job Requirement

  • Bachelor's degree or higher in STEM/Bio-medical education or relevant fields
  • At least 1 years of relevant working experience in Quality Assurance / Regulatory Affairs in structured medical device environments
  • Good knowledge in ISO 13485, HSA Regulations, and regional medical device regulations
  • Tactical mindset and strong problem solving skills
  • Excellent communication and interpersonal skills, with the ability to liaise with internal departments and external partners to gather and disseminate necessary information effectively
  • High level of attention to detail and precision in all aspects of work, from document preparation to regulatory compliance and quality assurance
  • Willingness to adapt to changing regulatory landscapes and commit to continuous learning and professional development in the field of healthcare regulation and supply chain management
  • Pro-active team player, mature, resourceful, meticulous, analytical and able to work independently
  • Able to speak Mandarin in order to liaise with business partners based in China
  • Proficiency in MS Office applications is a MUST

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