Regulatory Affairs Executive

Assist on technical regulatory requirement for country registration matter including product registration, certification, external testing, product, and standard compliances (e.g. FDA 510(k), Health Canada, PPE, Eudamed, etc).

Prepare, update and compile supporting documents for new and existing customer for country registration of Medical / examination / industrial gloves.

Search, analyse, review, and summarize latest standard and regulation requirements for gloves.

Provide support for issues related to regulatory and statutory requirements.

Assist on customer requests for information, such as product data, written regulatory affairs statement, surveys, or questionnaires.

Liaison with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review for establishment and product registration.

To prepare, review and update the technical files and all related regulatory documentation as necessary to obtain and sustain product approval.

Review product promotional materials, labelling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.

Manage customer complaints and coordinate CAPA.

1. Looking for candidates available to work:
   1. Monday: Morning
   2. Tuesday: Morning
   3. Wednesday: Morning
   4. Thursday: Morning
   5. Friday: Morning
2. 1 year of relevant work experience required for this role.
3. Working rights required for this role.
4. Expected start date for role: 01 February 2025.
5. Expected salary: RM3,200 - RM5,000 per month.