Quality & Regulatory Affairs Manager - Med Devices

23 Jun 2020

Quality & Regulatory Affairs Manager - Med Devices

A global medical device organization in Singapore with impressive revenues amid current climates has created a highly commercial and strategic managerial position, one that focuses in Quality and Regulatory Affairs for the ASEAN region. This multinational is always at the forefront when it comes to innovation and medical solutions hence one should inevitably grow and develop within this business

Reporting into the MD of the business, this role will predominantly entail the following responsibilities:

  • Overall quality systems management & regulatory affairs initiatives across the ASEAN region covering countries such as Singapore, Malaysia, Brunei, Philippines, Indonesia, Thailand and Vietnam
  • Quality and process improvement measures within and outside of the organization likewise managing product registrations, authority approvals, retention of policies, working instructions and field corrective actions to name a few
  • Being a custodian across ASEAN countries and an opinion leader for regulatory, quality and other process owners together with providing updates, root cause analyses (CAPA), quality system tasks (QEHS) and commercial impacts towards the business to senior management
  • Champion the relationships between regulatory bodies (HSA), be involved in audit exercises, manage integrated management systems (ISO 9001, ISO 13485, ISO 14001 & OHSAS 18001)

Skills & Requirements

  • Bachelor or higher academic Degree in Engineering, Business or relevant
  • At least 5 years of work experience within regulatory affairs in an international medical device firm
  • Experience of ISO 13485 management and other relevant integrated systems
  • Regional exposure in quality and regulatory affairs initiatives
  • Familiarity in working with regulatory bodies and authorities
  • Experience in managing a team would be desirable and able to portray leadership qualities
  • Owner of logical thinking and healthy judgment, practices open communications and able to receive constructive feedback
  • Ability to maintain sensitive attention to government actions related to medical device regulations and competitors' performance.
  • Capable in informing and working with manufacturers with regards to best practices towards regulatory practices
  • Adaptable, independent, resourceful and comfortable working under ambiguous working environments

If this sounds of interest to you, send us your updated CV or if you know someone suitable, we value such partnerships through our Referral Rewards Program. Do note that only shortlisted candidates will be notified

EA License No: 11C5502 | EA Reg No: R1985488

Jonathan Ong - R1985488's picture
Senior Consultant | Supply Chain & Procurement
Singapore +65 6818 3192 | jong@morganmckinley.com