Principal Task : The successful candidate will first and foremost be responsible for regulatory affairs and product registrations for all SciMed products. The candidate will be the focal point of contact for advice on regulatory guidelines and activities. Besides regulatory affairs, the candidate will also support the Management Representative in ensuring an effective Quality Management System (QMS) and local implementation of PHC’s compliance policies and ensure full adherence where necessary.

REQUIREMENTS

Candidates should bring with them

• A Degree in Life Sciences, Biomedical or any other related discipline.
• Minimum 2 years’ experience in performing a similar job scope.
• Relevant experience in regulatory affairs will be advantageous
• Good knowledge and application of Microsoft 365.
• Able to work under a matrix reporting structure.
• Good organizational and time management skills.
• A strong database experience (Access, Excel) to set up functions, enter data or process information.
• Excellent interpersonal, presentation and verbal/written communications skills.
• Meticulous, able to work independently and timely in meeting deadlines.
• Integrity with a history of ethical decision-making is essential
• Sound knowledge of the regulatory requirements and legal framework for products and industry trends in the Asian Region.
• Knowledge in GDPMD, ISO9001, IVDR preferred.
• Familiarity with Health Science Authority’s regulatory on medical devices, product registration, field safety correction and licensing requirements.

Please refer the Job description for details