Regulatory Manager

45000.00 - 50000.00 GBP Annual + GBP45000 - GBP50000/annum
19 Apr 2017
04 May 2017
Contract Type
Full Time
Our client A successful (Award Winning) Injection Moulding Business undergoing continuous expansion including a state of the art Class7 cleanroom facility. They operate in a diverse Market encompassing Technical, Automotive and Medical Products are recruiting a Regulatory Manager who alongside the established Quality Team can advise on legal requirements and facilitate the introduction of New Product to their Portfolio.

About the Individual:
•Regulatory Compliance experience in a similar environment.
•Smart and able to interact with Customers, Suppliers and Internal Stake holders.

Purpose of the Job
To Identify, implement and maintain Medical Device regulatory requirements for all existing and future needs of the business on Medical Devices.
To advise and support the business in understanding regulatory requirements/needs in understandable terms.
To ensure regulatory requirements are identified and met for the business, to ensure business compliance/risks.
To liaise with Customers to enable the regulatory requirements of medical devices responsibility are understood, determined and agreed at initial stages of enquiry/project.

Scope of job & key responsibilities
• Responsible to create, update, submit and maintain device technical files for OEM devices and where required by the business support Customers to undertake this.
• Responsible to research and maintain device regulatory vigilance and regulatory changes that affect the device business and communicate to Management and Customers.
• Responsible to liaise with regulatory or competent authorities as necessary to ensure compliance of device is maintained.
• Responsible for device artwork and IFU review and approval for all devices that the business has OEM/device responsibility or as defined in Technical Agreements with Customers.
• Responsible for research into devices/regulatory requirements to aid the business in meeting Customer needs and objectives for Medical Devices and ensuring business is appraised of the findings to make informative based decisions.

Main tasks & duties
• Maintenance and where necessary the creation of Technical Agreements.
• Technical File creation and maintenance for appropriate market device entry, i.e. CE, 510(k), TGA, as required.
• Regulatory submissions to appropriate authorities.
• Undertake regulatory and devices investigations to ensure business is kept compliant.
• To provide information for Management Review when requested presentation for this meeting.
• To inform and provide guidance/recommendation to current, new or proposed regulatory requirements.
• To ensure all technical files, dossiers and agreements held or utilised are maintained.
• To ensure packaging copy, IFU and advertising media for supplied MDD's (CE marked products) meet all legal requirements in the UK.
• To be an active project team member for all NPI projects.
• Provide brief presentations and when requested inductions on Regulatory systems.
• Working with all areas of the business and Customers to ensure business objectives for Medical Device are met.

Required skills & competences
• Minimum 3-5 years of experience in Regulatory affairs for Medical Devices
• Relevant background qualification in Regulatory affairs and/or quality in the Medical Device industry required
• Analytical and methodologist, persistent, fact based and strategic mindset,
• Good communication skills and able to communicate at all level in the business and to external parties, Customers & Regulatory bodies.
• Good understanding of customer expectations and requirements