Regulatory Admin

Main Job Tasks, Duties, and Responsibilities
Ensure compliance with local regulations regarding medical device registration requirements
- Maintain accurate records related to product registrations.
- Monitor changes in relevant legislation and communicate these changes internally.
- Coordinate with external stakeholders such as government agencies, consultants, distributors etc., on behalf of the organization.
- Provide advice/support to internal departments regarding regulatory matters.
- Review documentation submitted for approvals/licenses/certificates/permits etc., prior to submission.
- Collaborate with cross functional teams to ensure timely completion of tasks associated with product registrations.
- Work closely with manufacturers, suppliers, importers, exporters and other interested parties to facilitate smooth operations.
- Keep track and update NOT for product registration.
- Keep regulatory documents updated, and be well versed in auditing tasks for GMP, ISO and Halal.

Education and Experience
- Bachelor’s degree in Science, Life Science or equivalent preferred
- At least 5 years of experience in Regulatory Affairs preferably in the medical device industry
- Experience working on IVD's registration would be advantageous
- Strong understanding of local regulatory frameworks governing medical devices
- Excellent communication skills both written and verbal
- Ability to manage multiple projects simultaneously while meeting tight deadlines
- Detail oriented approach to work with a focus on accuracy and precision
- Highly organized individual capable of managing large amounts of data effectively
- Proven track record of successfully implementing complex processes
- Demonstrated ability to influence others through effective collaboration and negotiation techniques
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)

Key Competencies
- attention to detail
- communication skills - verbal and written
- data collection, management and analysis
- problem analysis and problem solving
- planning and organizing
- effective interaction with stakeholders
- teamwork

Pay: RM 2,000- RM per month

Schedule:

- Monday to Friday

Supplemental Pay:

- Attendance bonus
- Yearly bonus

Pay: RM1,500.00 - RM2,000.00 per month

**Benefits**:

- Health insurance
- Maternity leave

Schedule:

- Monday to Friday

Supplemental Pay:

- Attendance bonus
- Yearly bonus

Work Location: In person