Job title: Quality & Regulatory Manager
Job type: Permanent
Emp type: Full-time
Industry: Medical Device/Technology
Skills: Quality Management Systems ISO13485 Medical Device Medical Software MDR MDD Regulatory Affairs QMS
Salary: Negotiable
Location: Singapore
Job published: 2021-03-31
Job ID: 32414
Contact email: wendyc@talentreq.com

Job Description

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

 

Role

  • 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.

 

Requirements

  • 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