Regulatory Affair Associate (Medical Device)
- Participate in the development and lifecycle management of products to ensure compliance with all internal and external requirements for markets such as EU, US, Japan, Korea and APAC.
- Develop, implement and maintain regulatory strategies and regulatory submission plans in order to meet project milestones.
- Prepare, update and maintain technical files/submission dossiers as per applicable SOPs, and liaise with the relevant departments as required.
- Work with project teams to resolve complex project issues by strategically interpreting and clearly communicating regulatory requirements.
- Review and approve documents such as Engineering Change Orders, Design Change Notices and validation reports for scientific merit and regulatory appropriateness for compliance with international regulations and standards.
- Ensure labelling meets all relevant international requirements.
- Conduct regulatory assessments for change controls in line with international regulatory requirements.
- Support internal and external audits as required.
- Contribute to the review and improvement of regulatory processes.
- Min. degree or equivalent in sciences, medicine, pharmacy, engineering or another relevant discipline in the area of regulatory affairs or medical devices.
- Min. 3-5 years of experience in regulatory affairs and/or in quality management systems relating to medical devices, preferably with higher classes (e.g. III in EU) in a global or regional capacity.
- Knowledge of international regulations and standards for medical devices.
- Experience in ISO certification and audits will be advantageous.
- Experience with the manufacturing of high-tech medical products is preferred.
- Working knowledge and experience with competent authorities are an advantage.
Interested Candidates please forward your updated CVs to:
Alex Goh Hock Leong – R1763413 at [Click Here to Email Your Resume]
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