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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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At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

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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