Regulatory Affairs Quality Assurance, Quality

2 weeks ago


Ipoh, Malaysia Kimula Sdn. Bhd. Full time

**Regulatory Affairs (RA) cum Quality Assurance/Quality Control (QAQC) Specialist**

**Responsibilities**:
Regulatory Affairs:

- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and standards for medical devices.
- Prepare and submit regulatory submissions and documentation to obtain and maintain product approvals, registrations, and certifications.
- Monitor and interpret changes in relevant regulations and standards to ensure ongoing compliance.
- Interface with regulatory agencies during inspections, audits, and inquiries, addressing queries and providing requested information.
- Stay current with emerging regulatory trends, developments, and best practices in the medical device industry.

Quality Assurance/Quality Control (QAQC):

- Develop and implement QAQC procedures, policies, and processes to ensure product quality and compliance.
- Conduct thorough inspections, tests, and audits of incoming materials, in-process products, and finished goods to ensure conformity to specifications and standards.
- Manage and maintain QAQC documentation, including test reports, inspection records, and CAPA documentation.
- Investigate and analyze product non-conformities and quality incidents, implementing corrective and preventive actions (CAPAs) as needed.
- Support the development and implementation of quality control measures in manufacturing processes to ensure consistent and high-quality output.
- Collaborate with cross-functional teams to address quality-related issues, continuous improvement initiatives, and process optimization.

**Requirements**:

- Bachelor's degree in a relevant scientific or engineering discipline (e.g., Biology, Chemistry, Engineering).
- Minimum of 3-5 years of combined experience in regulatory affairs and quality assurance/quality control within the medical device industry.
- Strong knowledge of medical device regulations and standards (e.g., MDA, FDA, ISO, MDR).
- Experience in preparing and submitting regulatory submissions and managing regulatory interactions.
- Familiarity with quality management systems, quality control methodologies, and continuous improvement principles.
- Excellent problem-solving, analytical, and communication skills.
- Detail-oriented with a strong sense of accuracy and compliance.
- Ability to work collaboratively across departments and with regulatory authorities.
- Experience with solution-based medical devices, such as gels and solutions, is a plus.

**Salary**: RM3,500.00 - RM5,000.00 per month

Schedule:

- Monday to Friday

Ability to commute/relocate:

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

Expected Start Date: 08/28/2023


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