Regulatory and Compliance Assistance Manager
2 weeks ago
Regulatory
1. Write, analyze, and edit technical documents to support country
- specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents
2. Maintain regulatory files. Maintain and update regulatory authorizations for both medical devices and personal protective equipment.
3. Assure that appropriate maintenance of registrations occurs, including renewals, device listings, site registrations, supplements for changes, and annual reports. Support approval in other regions as required.
4. Assist in preparing responses to regulatory authorities' questions within assigned timelines.
5. Stay abreast of regulatory procedures and changes in regulatory climate.
6. Assess device-related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in a timely manner. Assist in handling recalls and field actions, if required.
7. Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
8. Support external regulatory agency and customer audits, providing regulatory input to minimize potential for findings of non-compliance.
9. Other duties as assigned.
**Compliance**:
1. Develop and implement health and safety plans, enforcing policies, assessing risk, and ensuring compliance within legal guidelines. Implement 5S and other lean-management tools to ensure a safer and more efficient workplace.
2. Conduct training, investigate incidents, and provide recommendations for improvement aiming to create a safe and compliant workplace environment
3. Coach and supervise HSE key staff as necessary.
4. With the assistance of external experts, responsible for the identification and monitoring of the main greenhouse gas emission (Scope 1, 2 & 3) as well as the implementation of action plan to further reduce IneoTech footprint, as well as regular follow-up
5. Establish Annual Compliance & Sustainability Report
Applicant must have either compliance or regulatory experience for this position.
Pay: RM4,000.00 - RM6,000.00 per month
**Benefits**:
- Free parking
- Health insurance
- Maternity leave
- Opportunities for promotion
- Parental leave
- Professional development
Schedule:
- Monday to Friday
Supplemental Pay:
- Performance bonus
Ability to commute/relocate:
- Simpang Ampat: Reliably commute or planning to relocate before starting work (required)
**Education**:
- Bachelor's (required)
**Experience**:
- Regulatory or Compliance: 3 years (required)
Work Location: In person
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