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Regulatory Affairs Officer Role, Washington

England, Tyne and Wear, Washington /
Permanent/Long Term /
£22000 - £37000 per annum
J121912
This vacancy has now expired.

Regulatory Affairs Officer - Washington

Are you currently working as a regulatory affairs officer and looking for an exciting new opportunity?

Our client is looking for a Regulatory Affairs Officer to join their rapidly growing organisation, who are very well placed in several 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.

Location

Washington

Key Information

  • Comprehensive understanding of regulatory requirements applicable to the company.
  • Working knowledge of 13485 & 93/42/EEC
  • Collate product information and keep updated for product ranges to enable use in export registration requests
  • Ensure technical files are maintained and reviewed regularly against all regulatory standards.
  • Ensure all licensing information is logged into Q Pulse system
  • Liaise with the Quality department on aspects of quality related documentation where required
  • Familiarisation with worldwide regulatory bodies and registration requirements
  • 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
  • In line with MDR ensure DMR are raised for all product codes and reviewed regularly

The Package

  • £22k to £37K Basic plus wider package
  • Company Bonus
  • Flexible working

Key Skills

  • Ideally looking for prior experience in regulatory affairs
  • 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 within Rocket Medical and with suppliers; it is essential that the jobholder has good interpersonal and communication skills
  • 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 wish to find out more please click the 'Apply' button. This will send a notification to the consultant looking after this vacancy who will get in touch at a suitable time to share further details on this opportunity. Any communication will be in complete confidence, without obligation and we will NOT send your details to any practice unless you give us your permission, so there is nothing to lose in finding out more!

If you wish to contact us about this opportunity and other suitable positions, please call our Medical Devices team on 01423 813456.

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