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Regulatory Assistant

Job LocationDerby
EducationNot Mentioned
Salary26,000 - 28,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Regulatory Assistant Ethero Derby are currently recruiting for a Regulatory Assistant to join our client based In Derby. Our client provides the best solution for medical, healthcare or nutritional packaging requirement, whether its providing the equipment needed to manage it in-house, a contracted out-sourced solution or simply specialist advice. They are both a leading supplierof packaging machines and complete packaging line solutions operating from a a state of the art 4,700 sq metre manufacturing facility tailor-made specifically for the manufacturing of medical packaging and products. It houses 10 Cleanrooms (two Class 8 andeight Class 7), each being either process or product specific.Salary: £26,000.00-£28,000.00 per year dependant on experience. We are looking for an organised team player with excellent communication and planning skills to join the Quality team. The role of Regulatory Assistant will see you assisting with maintaining the companys compliance to quality standards and EU regulationsand supporting the continued effectiveness of the Quality Management System. You must have relevant QMS/Regulatory educational or training qualifications with experience of Quality Management systems and Medical Device regulations alongside strong analyticaland literacy skills and a positive attitude.Main Responsibilities:

  • Assist with the upkeep of Technical files
  • Assist with on-time fulfilment of compliance and regulatory changes
  • Control and maintain product specifications
  • Maintain communications with EU representative on matters relating to compliance
  • Communicate with competent authorities on matters relating to new products, incidents and recalls
  • Provide support with product data collection and reviews
  • Participate with the change control process for new product introduction and alterations
  • Adhere to the Company hygiene and quality standards (GMP) at all times
  • To facilitate the development of an open and productive culture where people take pride and responsibility in what they do
  • Embrace the culture of continuous improvement without fear of putting forward new ideas
  • To demonstrate good employee relations within the team and to other departments
  • To facilitate the development of an open and productive culture where people take pride and responsibility in what they do
Additional Perks:
  • Quarterly and Yearly bonus scheme after completion of probation
  • Bike to work scheme
  • Company events
  • Company pension
  • Free On-site parking
Experience:Regulatory Affairs: 2 years (preferred)If you are interested in this position apply now or for a for information call Ella on .

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