Senior Regulatory Affairs Associate

Search Consultancy

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Job ID :

13030


Company Type :

Staffing Firms


Industry :

Science and Research


Education Level :

Bsc


Address 1 :

United Kingdom,North West,North West England,


Key Skills :

Regulatory Affairs, Class III devices, regulatory submissions


Salary :

Negotiable


Date Posted :

24 Sep, 2018



Company Name :

Search Consultancy


Location1 :

North West England




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

Senior Regulatory Affairs Advisor
Home based role
Salary up to £80K per annum

A fantastic opportunity has arisen to join a Global Medical Device company as a Senior Regulatory Affairs Advisor.

Reporting in to the Regulatory Affairs Manager, you will be expected to:

* Create and maintain Regulatory Files e.g. Technical Files, Design Dossiers, 510(k) submissions and PMA submissions.
* Submit and maintain regulatory affairs approvals.
* Provide independent regulatory guidance to business partners and cross function project teams including communicating details on the regulatory landscape and product submission requirements.

The ideal candidate for the Senior Regulatory Affairs Advisor role:

* A BSc or equivalent in a Life Sciences or related subject
* Previous experience in Medical Device Regulatory Affairs, particularly class III devices
* Demonstrated experience with compiling and submitting EU regulatory submissions (Class IIa, IIb, and III CE submissions) and US FDA 510(k) and/or PMA submissions is required.
* Working knowledge of European and US medical devices requirements and regulations is required. MUST have experience in Class III submissions.
* Strong communication and technical writing skills required.
* Position requires a minimum of 20% travel.

If you are experienced in dealing with submissions for class III medical devices then please apply now!

Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.


Company Name:

Search Consultancy


Headquarters:

Campbell House,215 West Campbell Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

G24TT


Website:

www.search.co.uk


Employees:

100 - 499


Industry:

Pharmaceutical


City:

Glasgow


Phone No. :

01618358600


For more information,visit www.search.co.uk.

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