Regulatory Affairs Specialist (6-month contract)

Company Description

Access-2-Healthcare is a global consulting company dedicated to helping small to medium sized medical technology organizations overcome various challenges and launch their products in the market. Founded in 2015, the company has local offices in 14 countries and is dedicated to getting the job done by providing expertise to doctors, start-ups, universities, hospitals, and Med Tech communities. The company aims to increase the range of innovations available to hospitals, clinics and patients alike in an effort to lower healthcare costs.

Role Description

This is a 6-month contract role for a Regulatory Affairs Specialist. The specialist will be responsible for regulatory documentation, submissions, and requirements, including requirements involving quality management systems and risk management. This is an on-site role located in Singapore with very flexible working arrangements. Role able to gravitate to a permanent role.

Qualifications

• Knowledge of regulatory requirements in the Singapore and ASEAN markets, EU MDR/IVDR a plus
• 1 to 3 years&apos experience in creating and submitting regulatory documents.
• Bachelor&aposs degree in Science, Engineering, Biomedical (to understand products more quickly)
• Singaporean or PR required
• Having a musical background preferred
• Multilingual skills a plus
• #Music or #teamsports background a plus