Regulatory Officer

2 weeks ago


Derby, Derby, United Kingdom Recruit 2 You Full time
Our client is a leading manufacturer in medical devices and medical packaging solutions.

They are looking for a Regulatory Officer to join their team based in Derby.


In this role you will help assist with maintaining the company's compliance regulations and to support the continued effectiveness of the Quality Management System.


Your responsibilities as the new Regulatory Officer:

  • Assist with the upkeep of technical files.
  • Assist with ontime fulfilment of compliance and regulatory changes.
  • Control and maintain product specifications.
  • Maintain communications with EU representatives 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 in the change control process for new product introduction and alterations.
  • Always adhere to the Company's hygiene and quality standards (GMP).
  • 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.
  • Agree personal appraisal targets with Manager.
  • 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.
  • To contribute towards maintaining, promoting and developing high standards of Health & Safety standards of self and others to comply with legal requirements.
  • Work towards the utilisation of Lean Manufacturing techniques in line with Company objectives to support the continuous improvement of the Company.
  • To carry out any other relevant tasks as may be required by circumstances or on request from the Company.

Requirements as the new Regulatory Officer:
Have relevant QMS/Regulatory educational and training qualifications

Experience and understanding of Quality Management systems and Medical Device regulations

Good computer skills to encompass Microsoft Office and Outlook

Excellent planning, communication, and organisational skills

Strong analytical and literacy skills

Able to work as part of a team and off own initiative, demonstrating a confident and competent approach to decision making

Have a positive attitude with a professional, patient, and approachable personality

Able to follow instructions and prioritise time to work productively to meet tight deadlines

About the role:

  • Monday
  • Friday.
  • Bike to work scheme.
  • Quarterly bonus
  • Free weekly fruit
  • Free tea and coffee
  • Onsite parking
  • Annual bonus
  • Annual leave 21 days + Bank Holidays

Job Types:
Full-time, Permanent

Benefits:

  • Company pension
  • Free parking
  • Onsite parking
  • Sick pay

Schedule:

  • Monday
to Friday

Work Location:
In person

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