Regulatory Affairs

1 week ago

Kota Damansara, Malaysia Recruit Express Full time

Identify regulatory and post market requirements for new products or product enhancements early in the product development cycle. Collect regulatory and post market requirements for Malaysia and other key markets in Southeast Asia.
- Gather information to support regulatory submission and related compliance activities. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims. Coordinate compulsory test in the region when there is the need.
- Review product revision requests to assure compliance with regulatory and post market requirements. Assess new product launch requirements and provide the regulatory information according to the needs.
- Work on product teams to develop regulatory strategy based on regulatory and post market requirements.
- Review and approve labelling and marketing literature, as needed.
- Support Director, RAQA APAC and other Regulatory Affairs staff with all regulatory and compliance matters. Conduct timely activities of supervisor assigned.
- Work with direct supervisor and senior internal stakeholders to identify key initiatives, which may be affected by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management.
- Lead the Recall and Adverse Event reporting in Malaysia and other key markets in Southeast Asia. Work with Compliance team and follow the regulation for Recall and Adverse Event reporting
- Archive and maintain all paper and electronic submission documents properly.
- Protect company confidential information by properly storing, retrieving, and disseminating such information only to those authorised
- Work with Director, RAQA APAC and cross-functionally with local team to assure the ISO 13485 and/or GDPMDS quality system operates in compliance with applicable regulatory standards, including participation in internal and external audits / inspections as well as supplier audits / inspections.
- Development / maintenance of local quality system processes, GDPMDS, ISO 13485 and/or customer audit facilitation and document control.
- Utilise CAPA (Corrective Action / Preventative Action) system, including issuance of CAPAs, tracking of open CAPAs, and reporting on CAPA effectiveness.

**Job Type**: Permanent

**Salary**: RM5,000.00 - RM6,000.00 per month

**Benefits**:

- Professional development

Schedule:

- Monday to Friday

Supplemental pay types:

- Commission pay

Ability to commute/relocate:

- Kota Damansara: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- SEA Regulatory Affairs: 3 years (preferred)
- Regulatory Standards: 4 years (preferred)

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