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 Regulatory Affairs Specialist will be responsible for ensuring regulatory compliance in all aspects of product development for our customers. 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
- Strong understanding of regulatory affairs and quality systems (ISO13485, GDPMDS) in the medical technology industry. Knowledge of regulatory requirements in the Singapore and ASEAN markets, EU MDR/IVDR a plus
- Minimum 2 years' experience in creating and submitting regulatory documents.
- Strong ability to work together with people from different countries and backgrounds.
- Bachelor's degree in Science of Engineering.
- Having a musical background preferred
- Multilingual skills a plus
- Singaporean or PR required.
