Exciting opportunity for a regulatory/quality management professional in medical device (hardware and software) industry with experience in both ISO13485, CE Mark and MDD/MDR regulations to join a dynamic growing healthcare company as a Quality and Regulatory Manager
- Establish and manage Quality Management System (QMS) regular updates to Senior Management team on any improvements performed on QMS.
- Spearhead the quality and regulatory functions for existing product/technology.
- Establish and manage a robust customer complaint handling system to manage complaints from global customers.
- Work closely with both technical and marketing partners in technical file preparations and with respective regulatory authorities/consultants for product registrations.
- Responsible for supporting the company’s Personal Data Protection Management Programme and ensure compliance with PDPA and EU GDPR data governance efforts.
- Lead Risk Management, CAPA, Quality Management System initiatives.
- Management Representative for Quality Management System (ISO 9001), Medical Device Standard (ISO 13485) and Medical Device Software Lifecycle Process (IEC 62304).
- Oversee internal quality audit programs to ensure compliance.
- Schedule quality-related project plans, along with the platform project team leaders, to fit them into the project deadlines.
- Meet customer expectations related to product's quality.
- Participate in Design Reviews, including review of design documents, to ensure new products meet regulatory requirements
- Responsible for product registrations in APAC (including ANZ) and EU countries, either directly or through distributor markets.
- Prepare product technical file/dossiers for regulatory submissions
- Liaise with respective regulatory authorities in regulatory submissions, proposals, analysis and submission of change notifications and provide timely response to input requests
- Responsible for regulatory plan for new products, including clinical study compliance and submission requirements.
- Maintain regulatory activities including updating the technical files, regulatory log files and post market regulatory activities such as post market surveillance, health hazard evaluation, medical device reporting and recall.
- Raise awareness on PDPA/ EU GDPR and foster a data protection culture within the organization, and provide scheduled training for all staff on PDPA/ EU GDPR requirements, regulations and guidelines.
- Responsible for the development of any data protection policies and procedures.
- Relevant Diploma or Degree with prior work experience in medical device or digital healthcare industry
- 5 years and above quality management experience
- Familiar with ISO 9001, ISO 13485 and IEC 62304 requirements and strong understanding of FDA 21 CFR Part 820 including IQ, OQ and PQ validation activities.
- Experience in establishing Quality Management System (QMS).
- Familiar with Risk Management Process, FMEA, CAPA, Quality Management System (QMS) requirements.
- Prior experience in a regulatory role advantageous.
- Excellent analytical and problem-solving skills.
- Good communication, presentation and organizational skills.
- Proficient in Microsoft Office and Minitab