JOB RESPONSIBILITIES
To lead to drive the development of the company's regulatory affairs strategy, compliances and documentations
In-charge of pre-market submissions to post-market surveillance activities
To ensure the smooth and effective processing of the MDSAP countries, EU, UK and local regulatory requirements in accordance with the company's regulatory strategies and plans. (i.e. US FDA 21 CFR part 820, EUMDR 2017/745 etc.)
To execute all regulatory activities including submission of new products or renewals until post-approval monitoring.
To execute compilation, review, coordination, submission, monitoring, follow up of regulatory submissions to
To ensure expedited processing in accordance with company timelines and targets.
To initiate respective steps or changes upon receipt of updates or news which may affect existing or planned regulatory submissions to ensure continuity of business.
To represent the company as the primary communication point with the local regulatory authorities, industry groups and relevant stakeholders.
To develop, implement and maintain the required regulatory standards, standard operating procedures and resource documents.
To review and ensure labelling is in compliance with country specific requirements.
To anticipate regulatory obstacles and emerging issues throughout the product life cycle.
Responsible for implementing and maintaining the effectiveness of quality management system.
JOB REQUIREMENTS
Minimum Diploma / Bachelor’s Degree in Applied Sciences or Engineering, preferably in medical-related discipline.
Have more than 5 years of Regulatory Affairs working experience in medical device or pharmaceutical industry in Asia Pacific region.
Excellent knowledge and experience in the regulatory process for medical devices.
Strong engagement with country regulatory authorities and industry counterparts.
Strong communication and documentation skills.
Possesses high accountability and problem-solving ability.