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Regulatory Affairs Registration Officer, Medical Devices, Leeds
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? One trained you will have the opportunity to work from home exclusively or do hybrid working for their North East or North London 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.
This is an excellent opportunity to join a fantastic medical device brand, who is highly established in the UK market.
CANDIDATES DO REQUIRE REGULATORY EXPERIENCE IN THE MEDICAL DEVICE MARKET
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.
- Monday - Thursday inclusive 9.00am - 5.00pm
- Friday 9.00am - 4.00pm/Flexi time
- Regulatory Reporting
- Advise on country requirements with regards to changes in regulatory reporting requirements for medical devices and ensure that the company processes are kept up-to-date.
- Assist in the business in meeting regulatory reporting obligations - when applicable - by liaising with relevant bodies and working with colleagues to progress the investigation and to keep all informed and updated as required.
- Ensure SOP's for these areas are correct at all times.
- Working knowledge of 93/42/EEC and 510(k) process.
- Collate technical information for use in regulatory registrations.
- Prepare and submit regulatory registration applications
- Ensure all registration information is logged into Q Pulse system.
- Liaise with the Quality department on aspects of quality related documentation where required.
- Work alongside NPD and Regulatory team to create technical documentation in support of registrations, if required.
- 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.
- Assist when required to cover any areas within the department as required.
- Advise on existing and changing non-EU and non-US regulations applicable to the business.
Package and Benefits
- Basic salary to £30k
- Flexitime working
- Work from home
- Company Pension & wider benefits
Key Skills, Qualifications and Client requirements
- Key attributes
- Undertake training and development as required.
- Self-Reliance with the ability to work with the minimum of supervision and on own initiative.
- The job entails interaction between departments within the business and with Regulatory Bodies; it is essential that the jobholder has good interpersonal and communication skills.
- It is essential that the jobholder exhibits a high level of conscientiousness, ethics and accuracy in all tasks or duties.
- Pleasant and well presented.
- Have a good telephone manner
- Good organisation skills and methodical approach to work is essential.
- 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