Aurora Lifesciences has now partnered with a market leading medical device company that specialises in life saving medical products. Our client is now in search for a Regulatory Affairs Specialist to join a team of pragmatic and driven individuals.
The Regulatory Affairs Specialist will be responsible for ensuring medical device regulatory compliance with national and international legislation for projects, product and new market clearance. The successful candidate will manage specific regulatory objectives to meet the company’s strategic plan and objectives in line with the MDR.
The Role
* To support in all matters relating to regulation and applicable legislation
* Development, management and maintenance of the company’s Technical Files and Design Dossiers
* Responsible for new country product application to market including country specific technical report generation and submission
* Administer regulatory aspects of new product development initiatives and notify applicable changes to the Notified Body
* Liaise with the company’s notified body / competent authority and oversee international submission processes. Host Notified Body Technical File audits.
* Provide regulatory advice to other departments and Project Teams as and when required.
* Responsible for PMS & PSUR
About You
* Experienced in working medical devices (ISO13485) standard
* In depth knowledge of Global Registrations
* Must be a m...