Regulatory Affairs Assistant
Our client an established company that provides quality supply and support both UK and internationally are currently looking to recruit a Regulatory Affairs Assistant to join their team. This is a busy role that would suit someone with previous experience within a similar role.
Role: Regulatory Affairs Assistant Where: Southampton outskirts Salary: c£28-32,000pa
Responsibilities will include:
- Assisting in the preparation of technical files
- Assisting with product registration activities with MHRA
- Assist in post market, vigilance and recall activities
- Reviewing and approving labelling and instructions for use
- Assisting in providing responses to regulatory agencies regarding product information or issues
- Assisting with staff training in regulatory policies or procedures.
- Assisting with audits and regulatory agency inspections
- Ensuring that ISO 9001, ISO13485 (Quality) and ISO 14001 (Environmental) standards are met
- Ensuring compliance with regulations
- Assisting with internal Audits
You will need:
- The ability to work as part of a team
- To be professional in your approach
- Data Analysis, analytical and problem-solving skills
- Excellent organisational skills and attention to detail
- Good communication skills both written and spoken
- The ability to work under pressure and to deadlines
- Ability to grasp new concepts quickly and to assimilate and evaluate scientific data
- Experience in Regulatory Affairs (Desirable)
- MDD, IVDD, MDR or IVDR experience (Desirable)
- ISO 13485:2016 experience (Desirable)
- IVD Medical device industry experience (Desirable)
- Familiarity with ERP/MRP software (Desirable)
- Technical report writing skills
If this role is of interest to you and you have the necessary skills and experience please don't hesitate to APPLY.
Please be aware this advert will remain open until the vacancy has been filled. Interviews will take place throughout this period, therefore we encourage you to apply early to avoid disappointment.
Tate is acting as an Employment Business in relation to this vacancy.
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