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 on-time 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:
· £32k - £35k There would be some negotiation for the right candidate.
· Monday – Friday.
· Bike to work scheme.
· Quarterly bonus
· Free weekly fruit
· Free tea and coffee
· On-site parking
· Annual bonus
· Annual leave 21 days + Bank Holidays
We invite suitably experienced candidates to apply by following the appropriate links or by contacting Recruit 2 You directly on 01773 252222 who are acting as an employment agency for this hire.
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