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Regulatory Affairs Specialist - 12 Month Contract - Southern

Competitive - Medical/Pharmaceutical - Regulatory
Ref: 230 Date Posted: Tuesday 09 Oct 2018
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Our client is looking for a Regulatory Affairs Specialist to work on contract for an initial period of 12 months to ensure the appropriate licensing, marketing and legal compliance (MDD/MDR) of Medical and Industrial manufactured products.


Key Result Areas


•           Ensuring continued compliance with all relevant regulatory and quality requirements

•           Timely identification and co-ordination of regulatory changes to ensure no negative impact on the business.

•           Successful completion of mandatory training

•           Compliance with Health & Safety and Environmental procedures.


Principal Responsibilities 

•           Liaise with QA/RA management throughout the global organisation to ensure the consistent global approach to regulatory compliance.

•           Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained.

•           Ensure current regulations and standards are available.

•           Generate and maintain the DMR/DofC.

•           Attend and support Design review activity and generate environmental checklist, labelling, IFU and ER checklist.

•           Manage ECR/ECO process including notification to S-BCs of changes which are notifiable under regulations.

•           Initial review of complaints to determine and record reportability.

•           Ensure reportable events are reported within timescales as required by all market regulations. Notify senior management as appropriate.

•           Determine whether FSCA is required and generate a Recall File as necessary. Manage all activities and ensure Recall file is regularly updated.

•           Support and supply information as required relating to Product Registration in any market including site /establishment registrations including FDA 510(k), CE Marking etc.

•           Support Change management process (ECR/ECO) and report changes to S-BCs as appropriate.



Other Related Duties 


•           Participate in Continuous Improvement activities

•           Undertake any assignment or duty as required by business needs.

•           Adequacy and regular review of Technical File /Risk Management in accordance with current regulations.

•           Maintenance of SOPs


Core Business Competencies


•           Customer Centricity

•           Employee Focus

•           Operational Excellence

•           INtegrity

•           Social INvolvement

•           INnovation


Qualifications and Experience


University degree in a scientific / engineering subject.  At least five to ten years’ experience in a regulatory or quality role for a medical device manufacturer.  Ability to perform ISO 9001 / 13485 audits and a good understanding of EU MDD/MDR, FDA QSR and JPAL requirements and other key international regulations covering medical and industrial devices.

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Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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