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Regulatory Affairs Specialist
Job Posted: 11 days ago
Salary: £ 50,000/Annum
Job Type: Permanent
Location: Wakefield, West Yorkshire
Expire in: 16 days
Job Description
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 methodical thinker, capable of making rational judgements from available information and meeting targets in agreed time scales. Ability to write detailed reports.
* The desire to learn on the job with the ability to grow their career within Medical Device Regulatory Affairs
* An excellent communicator
Benefits
* 27 Day Holiday + 8 Day Holiday
* Private Health Care
* Cycle to Work Scheme £2000
* Monthly Business Lunch
* Clear Development Pathway & Training
* 3 Days on Site 2 From Home
* 4 ½ Day Work Week
To apply for this role or to be considered for further roles, please click 'Apply Now' or contact Matthew Moulton at Aurora LifesciencesBefore You Apply
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