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Responsibilities:
- Develop and implement policies and procedures to ensure compliance with all relevant laws, regulations, and industry standards
- Monitor and assess compliance risks associated with the company's activities and make recommendations for risk mitigation
- Conduct regular reviews and audits of the company's compliance program to ensure effectiveness and identify areas for improvement
- Provide guidance and support to business units on compliance issues and questions
- Develop and deliver compliance training to employees
- Review and approve marketing materials and other communications to ensure compliance with relevant regulations
- Monitor and report on regulatory changes and industry trends that may impact the company's compliance obligations
- Oversee the company's complaints handling process and ensure that complaints are handled in a timely and appropriate manner
- Assist with regulatory filings and respond to regulatory inquiries and requests for information
- Performs other related duties as assigned.
Requirement:
- Bachelor Degree in Engineering / Science or equivalent
- Min 5 years working experiences in quality /compliance /regulatory affair.
- Must have Knowledge of ISO 13485
- Must have Quality auditing experience or exposure to quality audit environment.
Plan and execute necessary activities within the plant before, during and after the audits, internal and external.
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