A medical device company is seeking someone who can provide International Regulatory Affairs support for Middle East region, to support coworkers in marketing, sales, operations and other company stakeholders.
Client Details
A leading multinational medical devices corporation.
Description
The Medical Device - Regulatory Affairs Specialist will:
- Work closely with company manufacturers, global regulatory leaders, on registration projects to region.
- Compile technical dossiers as part of submissions for new products and re-registrations including preparation of regulatory documents, certificates and specific forms for each country.
- Management of regulatory submissions for the marketing authorisation applications, devices listing, product variations, license renewals, etc., according to the Health Authorities requirements and company standards.
- Work closely with company distributors and support tender quires in region.
- Label artworks review for all product labels, insert IFU artworks to ensure compliance with the regulations of each country. Also, review applicable translations for appropriateness of claims and compliance with requirements.
- Create and maintain tracker for all company product's registration approvals and submissions at MEATI region.
Profile
The Medical Device - Regulatory Affairs Specialist MUST have:- 3-5 years of Regulatory Affairs experience in Middle East within a Multinational Medical Devices company. (Must be medical device, Pharmaceutical will not be considered)
- High sense of urgency, prioritise tasks according to potentiality with ability to manage multiple priorities.
- Organised and good sense of planning.
- Quick learner- should be able to adapt to new tasks swiftly.
Job Offer
To be discussed upon successful application.
Job Details
| Posted Date: | 2019-03-20 |
| Job Location: | Dubai, United Arab Emirates |
| Job Role: | Quality Control |
| Company Industry: | Healthcare, other |
Preferred Candidate
| Career Level: | Mid Career |
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