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Compliance Executive

2 weeks ago

Shah Alam, Malaysia Infinity Medical Sdn Bhd Full time

**About Us**:
We are a leading medical device distribution company committed to delivering quality healthcare solutions. Our operations align strictly with Malaysian regulations, including Good Distribution Practice for Medical Devices (GDPMD) standards. We are seeking a meticulous and experienced **Compliance Officer** to ensure our practices adhere to regulatory requirements and industry best practices.

**Key Responsibilities**:

- Develop, implement, and monitor compliance programs aligned with GDPMD and Malaysian medical device regulations.
- Conduct regular internal audits to assess compliance with GDPMD standards and identify areas for improvement.
- Ensure all operations, policies, and procedures meet the Medical Device Authority (MDA) requirements and other legal frameworks.
- Prepare for and manage external audits conducted by regulatory authorities.
- Maintain up-to-date knowledge of GDPMD and legal regulations, communicating changes to relevant stakeholders.
- Assist in the development of training programs to educate staff on compliance standards and legal requirements.
- Oversee proper documentation, including licenses, permits, and audit records.
- Provide expert advice on regulatory requirements for new product registrations or distribution processes.

**Requirements**:

- Bachelor’s degree in Biomedical Engineering, Healthcare Administration, Regulatory Affairs, or a related field.
- At least 3-5 years of experience in GDPMD compliance, legal regulatory affairs, or related roles in the medical device industry.
- In-depth knowledge of GDPMD standards, MDA guidelines, and relevant Malaysian laws.
- Proven experience in conducting internal and external audits.
- Strong analytical skills with a detail-oriented approach.
- Excellent communication skills for liaising with internal teams, external auditors, and regulatory authorities.

**Job Types**: Full-time, Permanent

Pay: RM3,000.00 - RM5,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Free parking
- Health insurance
- Maternity leave
- Opportunities for promotion
- Parental leave
- Professional development

Schedule:

- Monday to Friday