Regulatory Affair Officer

2 days ago

Sungai Petani, Malaysia Ideal Healthcare Sdn Bhd Full time

**Responsibilities of this role**:
**Regulatory Activities**:
ii) Stay updated about changes in regulatory requirements, guidelines, and industry best practices.

**Regulatory Compliance**:
i) Monitor and ensure ongoing compliance with all applicable regulations and guidelines to maintain necessary licenses, certifications, and approvals.

**Quality Systems Oversight**:
i) Collaborate with the quality assurance and quality control teams to ensure that all quality systems and processes comply with relevant regulations and standards.

**Audit**:
i) Prepare for and participate in external and internal audits, ensuring compliance with all applicable regulations, standards and accreditations.

**Data Analysis and Reporting**:
i) Analyze quality-related data to identify trends, patterns, and areas for improvement. ii) Prepare weekly, monthly reports or presentation on required scope for superior or management.

**Process Improvement**:
i) Collaborate with departments to identify process improvements and efficiency enhancements in quality related activities.

**Training and Education**:
i) Coordinate and deliver training programs on quality management principles and practices to educate staff and enhance awareness of quality objectives and procedures.

**Skills needed**:
i) Minimum with Diploma qualification in Science or related field.
ii) In-dept understanding of industry regulations, guidelines and company policies.
iii) Great team player with the ability to work with mínimal supervision.
iv) Basic knowledge in MS tools (Word, Excel, Power Point).
v) Written, communication reporting skills.
vi) Analytical and problem solving skills.
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- **About Ideal Health Care Sdn Bhd**:
Established in 1999 by Dato' Seri Dr. Haji Haminnuddin Bin Haji Abdul Hamid, Ideal Healthcare Sdn Bhd (IHSB) is a leading player in the global medical device industry. Specializing in manufacturing and distribution, IHSB has gained recognition for its commitment to quality and customer satisfaction. With over 20 years of experience, the company recently completed the IHSB Centre of Excellence (COE), a state-of-the-art facility, showcasing its dedication to meeting the increasing global demand for its offerings. As a substantial supplier to the Ministry of Health Malaysia since 2005 and with a presence in over 20 countries, IHSB aims to be a renowned brand in the future.

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

**Salary**: RM1,800.00 - RM2,500.00 per month

**Benefits**:

- Free parking
- Maternity leave

Schedule:

- Monday to Friday

**Education**:

- Diploma/Advanced Diploma (required)

**Experience**:

- Science Education: 2 years (required)

Ability to Commute:

- Sungai Petani (required)

Ability to Relocate:

- Sungai Petani: Relocate before starting work (required)

Willingness to travel:

- 75% (required)

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