Senior / Executive, Regulatory Affairs

1 week ago

Singapore Hays Full time

**Your new company**

A leading medical device MNC looking for a RA specialist to join their team

**Your new role**
- Compile and manage regulatory submissions for the assigned country/area in APAC region: process registration of new products, change notifications and renewals with the relevant authorities, as well as keeping close track of the registration status.
- Provide regulatory submission strategies for new products and assess the regulatory impact of product / process changes to RA Manager.
- Keep abreast of the regulatory changes or trends in SEA countries and ensure compliance.
- Provides recommendations on reportability of adverse events.
- Follow up on product post-approval commitments to authorities.
- Support other Regional RA registration team on Free Sale Certificates and other documents required for product registration. Includes legalization and notarization of documents.
- Manage administrative duties as well as ad-hoc projects assigned by immediate superior.

**What you'll need to succeed**
- At least 3 years of relevant regulatory affairs experience in medical device industry
- Knowledge in regulatory requirements of Class III medical devices in SEA or APAC region.
- Min. Bachelor’s degree holder in Life Sciences
- Experience in compiling packages or dossiers in the countries' format, e.g. STED format, CSDT format

**What you'll get in return**

You will be part of a leading organization who values employees and have a structured career growth with development opportunities. You will also be compensated with attractive remunerations.

**What you need to do now**

Registration ID No. R1330566 EA License No.: 07C3924 Company Registration No: 200609504D

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