Regional Regulatory and Quality Manager - based in Singapore - Access-2-Healthcare｜Meet.jobs

• The Job in Brief In lieu of business expansion, Access-2-Healthcare is hoping to chance upon a technical professional passionate about healthcare and medical technology to join our incredible multinational family.

The regional Regulatory and Quality manager helps to execute and deliver regulatory approval projects in the Singapore and South East Asia markets, as well as lead quality compliance projects in Singapore and abroad.

Based in our HQ country Singapore, this regional Regulatory Affairs and Quality manager will help to enable many small/medium sized medical technology companies realise their aspirations of gaining entry in their desired markets. The manager would also work with clinical and academic organisations, to help turn clinician’s innovations into reality.

This role is perfect for a MedTech professional who have had several years of practical experience in quality systems / regulatory and is raring to try, learn something different to expand their skillset and portfolio.
The regional Regulatory and Quality manager not only receives remuneration, but has the opportunity to learn from the top experts in the Medical Device world, as well as the ins and outs of running a small business in a challenging environment - stuff you can't learn just anywhere!

• What's the job about?
  Project Support for Singapore based projects relating to training and executional consulting in regulatory affairs and quality compliance
  Face-to-face / online meetings with the business prospect(s) during project acquisition, and with the client(s) during project execution
  Verify and review collected requirements/specifications from client.
  Completing technical files, procedures, and technical reports relating to quality, regulatory, business due diligence.
  Resource/project management of other team members in various countries for company-wide projects
  Follow up on project status and stay in close contact with clients.
  Any Singapore-based project execution task as assigned by Company and working in tandem with other team members.
  Administrative tasks, including but not limited to: create presentation materials, internal documentation for the company, errands, technical research
  Some travel is expected to attend regional meetings

• Required Technical Requirements
  At least 4 years’ working experience, preferably in the medical device or pharmaceutical industry
  Diploma or above, Degree preferred
  Implementation experience and technical familiarity with ISO13485, ISO14971, US QSR, J-QMS
  Executional experience in obtaining or supporting regulatory approvals, in the US, the EU, South East Asia, and interfacing

MUST-HAVE - Worked or have exposure to healthcare / medical technology related fields
MUST HAVE - Singapore citizen or Permanent Resident

Familiarisation with medical technology standards and regulations
Managed projects of various nature
Able to converse and write in Chinese preferred

• Qualities we value Reliable Hard worker Willing to learn