To ensure compliance with all applicable regulatory requirements for scientific and medical devices
To prepare & submit reports, applications/amendments to regulatory authorities
To keep up-to-date regulatory changes and requirements
To register new medical devices and submit change notification and also renewals
To work closely with regulatory agencies to ensure all pre and post-market registration issues as well as additional input requests were submitted before required due date
To work closely with regulatory representatives of suppliers for information and product update
To develop and implement strategies for new and existing products
To give advice during product development stage to ensure regulatory compliance
To organise and maintain accurate regulatory files and documentation
To work closely with Quality Assurance team for regulatory compliance
To support internal & external client audits preparation and handling
To collaborate with cross-functional teams to ensure regulatory requirements are integrated before launch
To identify & access risk
To develop strategies for risk mitigation
To monitor & evaluate post-market safety data and advert reports
To report promptly of any adverse events to the regulatory authorities when necessary
To ensure that relevant stakeholders are trained and informed on updates when necessary
Requirements
Min 3 years of relevant experience
Familiar with relevant regulatory guidelines and standards - ISO 9001, ISO 13485, FDA, CE, EMA and others
Bachelor's degree in related field
Attention to detail and organisational skills
Able to work independently and also in a team
Strong analytical and problem-solving skills
Proficient in MS Office Suite
Excellent written and verbal communication skills
Certification in Regulatory Affairs would be an added advantage
