Regulatory Affairs Registration Officer- North East - Work from home Options

J279838_1713921413 Tyne & Wear England £30K - £40K / Year

Regulatory Affairs Registration Officer - Medical Devices.

Are you working in regulatory affairs in the medical sector and could be looking for an exciting new opportunity to join a growing UK manufacturer of market leading medical products? Once trained you will have the opportunity to work from home exclusively or do hybrid working in their North East offices.

Our client is looking for a Regulatory Affairs Officer to join their rapidly growing organisation, who are very well placed in a number of consumable product areas including; Respiratory, Cardiothoracic, Chest Drainage, Fertility and Labour Ward devices.

You will join an existing team, working to cover and maintain the RA/QA system in accordance with the latest relevant standards for the product ranges produced. Assist in registration of devices with worldwide regulatory bodies and collate the necessary information.

This is an excellent opportunity to join a fantastic medical device brand, who is highly established in the UK market.

CANDIDATES REQUIRE DIRECT REGULATORY EXPERIENCE IN THE MEDICAL DEVICE MARKET

Job Summary

Assist in meeting regulatory requirements including undertaking registration of medical devices with worldwide regulatory bodies. Review complaints in a timely manner against the established medical device regulatory reporting requirements (e.g. vigilance), as applicable to the product in question, to determine whether those reporting requirements have been met. Work as part of a team to ensure reporting obligations are fulfilled where reporting requirements have been met.

Working Hours -

Monday - Thursday inclusive 9.00am - 5.00pm
Friday 9.00am - 4.00pm/Flexi time

Territory Details

• UK Portfolio

Key Duties

Regulatory Reporting:

• Comprehensive understanding of regulatory requirements applicable to the company.
• Working knowledge of 13485 & 93/42/EEC & MDSAP
• Ensure technical files are maintained and reviewed regularly against all regulatory standards.
• In Q Pulse System ensure all codes are allocated to relevant technical files, obsoleting and archiving as appropriate.
• Ensure Declarations of Conformity up kept up to date and embed into Q Pulse System.
• Allocate GMDN code nomenclature and name to all products.
• On MHRA website ensure all information is current and up to date.
• Liaise with the Quality department on aspects of quality related documentation where required.
• Work to current MDR.
• Work alongside NPD in the process of incorporating new products into the business, ensuring all relevant documentation is available and stored in the correct areas for easy access.
• Update any relevant databases as assigned.
• Any other tasks that are deemed necessary to fulfil the job role to the satisfaction of the company objectives.
• Ensure naming conventions are consistent throughout all documentation.
• Cover for other areas in the department when required - Registrations

Package and Benefits

• Basic salary to £40k
• Flexitime working
• Work from home
• Company Pension & wider benefits - Life insurance, Healthshield, Perkbox

Key Skills, Qualifications and Client requirements

Key attributes

• DIRECT REGULATORY EXPERIENCE IN MEDICAL DEVICE MARKET
• Undertake training and development as required.
• Self-Reliance with the ability to work with the minimum of supervision, on his/her own initiative.
• The job entails interaction between departments internally and with external suppliers; it is essential that the jobholder has good interpersonal and communication skills.
• It is essential that the jobholder exhibits a high level of conscientiousness and accuracy in all tasks or duties.
• Pleasant and well presented.
• Have a good telephone manner
• Good organisation skills and methodical approach to work
• The jobholder must maintain and uphold the company values

What Happens Next?

If you are interested in finding out more about this role please click the 'Apply' button. On submission of the job application form, an email alert is sent to the specialist consultant handling this role to register your interest.

All dialogue with us is in the strictest of confidence, without any obligation and we will NOT send your details to the relevant business without your consent.

Alternatively, to find out more about this role or any other roles that maybe relevant, you can email us at [email protected] or call our Medical Devices team on 01423 813456

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