Regulatory Affairs & Quality Assurance Specialist

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Due to continued expansion we are now recruiting for an experienced Regulatory Affairs & Quality Assurance specialist to join our client within Medical Devices. The role will follow the regulatory strategy for assigned corporate projects and write, file and obtain approvals for international regulatory submissions.

This role will work across Africa, Turkey the Middle East and India.

Essential Functions:

* The RA&QA Manager will ensure the company complies with the regulatory requirements and international standards within the region.

* The Regulatory Affairs Manager prepares registration dossiers for approval in EU, Africa and Central Eurasia

* Initiates IFUs and required product labelling in line with relevant EU, Africa and Central Eurasia requirements.

* Prepares Technical Files for CE approval

* Regulatory & Quality Assurance Manager represents the perspective of regulatory affairs to the company.

* Interprets general business objectives and effectively presents information to manager and regions.

* Reviews and approves product labelling.

* Supports "Own Brand" and "Private label " customers on RA/QA activities

* Liaises with Competent Authorities and Ministries of health within the region

* Provides input to Regulatory Affairs Impact Documents (RAIDS) from an EU, Africa and Central Eurasia perspective.

* The Regulatory Affairs & Quality Assurance specialist maintains good visibility of Distributors processes and importation requirements

* Maintains a presence at professional societies and contributes to the development of regulatory affairs and legislation.

* Responsible for exhibiting professional behaviour with internal and external business associates that reflects positively on the company

* Proactively acts as a resource to the regions on RA/QA issues and proposes changes to minimise risks and enhance quality, reliability, safety and productivity.

* Maintains ISO 13485 certification

* Performs audits on 3rd party distributors in the EU, Africa and Central Eurasia

* Performs tracks and records recall activities

* Writes SOP

Experience Skills and Knowledge

* Regulatory Affairs knowledge in an international environment

* Understanding of ISO 13485 requirements and EU medical device regulations.

* Ability to read and understand technical material.

* Auditing experience

* Excellent attention to detail & organization skills

* Excellent written and verbal communication skills.

* Computer literate, with intermediate skill in the use of Word, Excel and Outlook, and some knowledge of relational database systems, e.g. Agile Project Management system.

* Ability to work effectively either alone or as part of a team. Managing time effectively and completing tasks on time with general supervision.

* Experienced at reviewing and approving product labelling.

* Flexible and able to self-manage multiple priorities.

* Able to work effectively in multinational/multicultural environments.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales