Quality Officer

1 week ago

Bayan Lepas, Malaysia Leonix Sdn Bhd Full time

**Responsibilities**:
Regulatory Compliance: Ensure compliance with all relevant regulations, laws, and guidelines pertaining to [industry/sector] products/services in various jurisdictions.

Documentation Management: Develop and maintain regulatory documentation, including product registrations, submissions, dossiers, and technical files.

Regulatory Strategy: Collaborate with cross-functional teams to develop and execute regulatory strategies, including product approvals, licensing, and post-market surveillance.

Risk Assessment: Conduct risk assessments to identify potential regulatory issues and provide recommendations to mitigate risks.

Regulatory Submissions: Prepare, review, and submit regulatory filings to regulatory authorities, such as FDA, MDR, and other relevant bodies.

Quality Assurance: Ensure compliance with quality management systems and standards, such as ISO 13485 and Good Manufacturing Practices (GMP).

Regulatory Intelligence: Stay up-to-date with regulatory developments, changes, and trends in the medical devices landscape and communicate their impact to relevant stakeholders.

Interdepartmental Collaboration: Collaborate with cross-functional teams, including R&D, quality assurance, clinical affairs, and marketing, to ensure regulatory requirements are met throughout the product lifecycle.

Audits and Inspections: Assist in internal and external audits and inspections to ensure regulatory compliance and address any findings or deficiencies.

Training and Education: Provide training and guidance to internal stakeholders on regulatory requirements, policies, and procedures.

Qualifications:

- Bachelor's or Master's degree in a related field (e.g., Regulatory Affairs, Life Sciences, Biomedical Engineering).
- Strong knowledge of relevant regulations and guidelines in [industry/sector] (e.g., FDA, EMA, ICH, ISO).
- Experience in regulatory affairs within the medical device industry, preferably.
- Familiarity with quality management systems (e.g., ISO 13485, ISO 9001) and regulatory compliance standards.
- Excellent analytical and problem-solving skills with a keen attention to detail.
- Effective communication and interpersonal skills to collaborate with internal teams and external stakeholders.
- Ability to prioritize tasks and work independently in a fast-paced environment.
- Proficiency in using regulatory databases, document management systems, and Microsoft Office Suite.

Pay: RM2,500.00 - RM3,000.00 per month

**Benefits**:

- Health insurance
- Maternity leave
- Opportunities for promotion
- Parental leave
- Professional development

Supplemental pay types:

- Attendance bonus
- Overtime pay

Ability to commute/relocate:

- Batu Maung: Reliably commute or planning to relocate before starting work (preferred)

Application Question(s):

- Keen on taking the challenge together with the team?

**Education**:

- Bachelor's (preferred)

**Experience**:

- Regulatory Affairs: 1 year (preferred)

**Language**:

- English, Malay (preferred)

Willingness to travel:

- 50% (preferred)

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