Regulatory Affairs Specialist, Asean

2 days ago

Singapore DN & ASSOCIATES EXECUTIVE SEARCH PTE. LTD. Full time

Our client is a global medical device company and leader in new product development and medical education. They are pioneers in their speciality and every year, develop over a thousand innovative and specialised surgical products. Their mission is simple; to better the lives of the millions of patients using their products worldwide.

They are looking for a Regulatory Affairs Specialist to partner with them in their growing business. Reporting to the RAQA Director, APAC, you will be responsible for the daily operations of regulatory affairs and ensure regulatory submission compliance for submissions. You maintain understanding and compliance requirements of regulatory affairs affecting company operations and products. For new products or changes to existing regulatory submissions, you will be responsible for generating and managing submission documents.

**Responsibilities
- Writes, prepares, submits regulatory documents for the ASEAN market (For distributors and ASEAN subsidiaries)
- Communicates with regulators on submission projects
- Prioritizes and organizes multiples projects and competing priorities
- Participates in Regulatory Affairs planning for ASEAN markets
- Supports in APAC level projects as and when needed
- Review the product labelling and DFU, if any translation is required.

2. RA Compliance and Document control
- Regularly maintain and update product registration and listing databases for the assigned country.
- Change control of already-approved products including regulatory submissions
- Collects and assesses product change information to take necessary actions

3. Education and training for developing skills
- Attends seminars, lectures and academic conferences to collect and share information
- Keep abreast of latest updates from the ASEAN regulations related to Company products and ensures that the company is aware, ready and able to comply with the necessary regulations

4. Recall and complaint support
- Support in product safety alert activities and field actions.
- Assists in Post market surveillance (complaint, PER, AE report, and/or any regulatory FDA body in the assigned country).
- Participates in Quality System Audits by internal / external auditor.

**Requirements**:
EA License ID: 11C3242
EA Registration ID: R1108969

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