Regulatory Affairs

2 weeks ago

Singapore SCIMED (ASIA) PTE LTD Full time

**ROLES & RESPONSIBILITIES
**1. Regulatory Affairs**
- Understand relevant regulatory regulations, policies & procedures behind the company’s business activities and products
- Ensure product and company’s compliance with regulations for maintenance of approvals
- Maintain ISO and GDPMDS records, and work closely with the ISO/GDPMDS team to provide timely updates on company’s regulatory and licensing matters
- Advise management on regulatory processes, compliance and updates to policies
- Responsible for the maintenance of regulatory documentation databases
- Develop and maintain communication with regulatory agencies regarding submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions and reviews
- Main contact point for various regulatory-related internal inquiries regarding logistics, pre/post-marketing events in addressing customers’ requirements.
- Support the country managers in medical device regulations or other regulations for regional countries
- Liaise with related departments in the PHC Group

**2. Quality Management System**
- Support the Management Representative in the company quality management system
- Prepare for internal and external audits and ensure successful outcomes, tackle audit findings and recommendations in a timely manner
- Follow-up and verify corrective/preventive action (CAPA) effectiveness.

**3. Compliance**
- Support the Compliance Manager in implementing PHC’s compliance program and policies
- Coordinate, schedule and conduct required compliance orientation and training for employees
- Responsible to ensure compliance to regulations related to export controls
- Manage the contracts database and business licenses, including reviewing contracts and liaising with the PHC Group legal team.

**REQUIREMENTS**
- 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
- 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.

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