Regulatory Affairs Executive

3 days ago

Singapore FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD. Full time

Full awareness of local Health Products and Medical Device Act and their regulations relevant to the business through regularly checking HSA websites and attending HSA briefings;
- Communicate changes and new requirements to management;
- Meet, discuss and negotiate with HSA regulators on matters pertaining to product registrations;
- Have working knowledge of current products sold and keep abreast of new product launches by having regular update meetings with all the selling division managers;
- Assist Senior Manager, Regulatory Affairs for matters pertaining to regulatory affairs as and when required;
- Communicate with manufacturers, the local regulatory requirements, in order to facilitate the provision of appropriate documents for submission to HSA for product registration/amendments and compliance to local regulations;
- Work with regulatory partners/distributors to obtain successful registration of new products.
- Coordinate, facilitate, monitor, and track all regulatory activities in each market,
- Comply with reporting requirements of local authority
- Regulatory reporting for recalls, FSCAs, Adverse Events and complaint handling;
- Ensure compliance with GDPMDS;
- Ensure conduct of business according to local regulations for medical devices;
- Participate in GDPMDS internal and external audits
- Maintain and update regulatory-related databases, SOP
- Registers complaint with samples to manufacturer. Follow-up on reply from manufacturer.
- Any other duties assigned

**Professional Competencies**:

- General Degree (preferred in discipline of Biomedical Science or Biomedical Engineering)
- Preferred 1 year working experience or completion of Internship in the related field
- Familar with local and regional regulatory affairs requirements (medical devices)

**Personal Competencies**:

- Good interpersonal relationship skills
- Good written and verbal communication skills
- Project Management Skills
- Good organization skills
- Team spirit, Proactive, motivated, self starter

Salary range differs according to seniority.

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