Responsible for activities which lead to and maintain regulatory approval to market medical devices in Singapore Philippines and Myanmar. Develops and implements strategies for earliest possible approvals. Ensures timely preparation and submission of technical/regulatory documents to the authorities for product registration. Builds rapport with regulatory agencies. Anticipates regulatory enviroment change and actively manages the regulatory intelligence for new policy, regulation and requirements.
Also responsible for a variety of quality and compliance activities including but not limited to QMS maintainence, product complaint handing, adverse events reporting, and the administration of training management systems.
Manage the regulatory approval or registration of medical devices
Develop registration strategies, prioritizing assignments, implementing regulatory plan and coordinating multiple projects and activities in accordance with strategic company objectives, annual plan, and LRP targets.
Research regulatory requirements for assigned geographies , if required
Monitor emerging trends and integrate new requirements into registration and approval strategies
Monitor and disseminate information on changes to local, regional and global medical device laws & regulations affecting registration, manufacture, distribution and sale & marketing of Abbott products
Review, analyze and co-ordinate data for new product submissions, line extensions, variations to marketed products according to priority. Monitor the progress of marketing applications and provide management with a monthly registration status report.
Cultivation of professional working relationships with local regulatory authorities and local medical device industry association
Quality Compliance Responsibilities:
Appointed as management representative to ensure compliance with internal QMS requirements as well as Good Distribution Practice for Medical Devices (GDPMDS) :
Ensuring the GDPMDS regulatory compliance system is established, implemented and maintained;
reporting to top management on the performance of the GDPMD regulatory compliance system, as well as to identify and correct deviations from the established GDPMD regulatory compliance system;
ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain; and
liaising with external parties on matters relating to the Singapore medical device regulatory requirements.
Responsible for product experience handling and vigilance reporting to competent authorities
Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities, field actions or review of proposed device changes
Manage the maintenance and support of the training management systems
Review and approval of A&P materials to ensure compliance with local regulations.
MINIMUM EDUCATION REQUIRED:
Bachelor degree or dipolma in any training with more than 5 years of relevant experience.
Experience gained in multinational companies, especially in Medical devices and will be an advantage.
MINIMUM EXPERIENCE REQUIRED:
Experience in regulatory affairs, QMS, compliance and/or clinical investigations knowledge of regulations applicable to the business
Good judgement, ability to prioritize and resource regulatory activity according to business needs
Good interpersonal & communication skills, negotiation & communication skills