Regulatory Affairs Registration Officer
Tyne and Wear
Our client are specialists in their market sector, they are looking for a skilled Regulatory Affairs Registration Officer to join their team on a permanent basis.
The Job You’ll do
- Assist in meeting regulatory requirements including undertaking registration of devices with worldwide regulatory bodies.
- Review complaints in a timely manner against the established device regulatory reporting requirements (e.g. vigilance), as applicable to the product in question, to determine whether those reporting requirements have been met. Work as part of a team to ensure reporting obligations are fulfilled where reporting requirements have been met.
- Advise on country requirements with regards to changes in regulatory reporting requirements for devices and ensure that the client processes are kept up-to-date.
- Assist in client meeting regulatory reporting obligations – when applicable – by liaising with relevant bodies and working with colleagues to progress the investigation and to keep all informed and updated as required.
- Ensure SOP’s for these areas are correct at all times.
- Working knowledge of 93/42/EEC and 510(k) process.
- Collate technical information for use in regulatory registrations.
- Prepare and submit regulatory registration applications
- Ensure all registration information is logged into Q Pulse system.
- Liaise with the Quality department on aspects of quality related documentation where required.
- Work alongside NPD and Regulatory team to create technical documentation in support of registrations, if required.
- Any other tasks that are deemed necessary to fulfil the job role to the satisfaction of the company objectives.
- Ensure naming conventions are consistent throughout all documentation.
- English and Maths GCSE Grade C or above or equivalent.
- Hold a degree or equivalent vocational experience in a life science.
- Excellent IT skills including Microsoft applications.
- Experience of handling sensitive or confidential information.
- Working knowledge of 13485, 93/42/EEC & 510(k).
- Has an understanding of Regulatory Bodies product and company registration routes/requirements.
- Effective communication with regulatory authorities.
- Knowledge of drafting Registration Applications.
- Able to motivate and provide guidance on registration process.
- Excellent Communication Skills within all levels of organisation and with Regulatory Bodies.
- Able to manage and take responsibility for workload commitments, planning and prioritising.
- Self-motivated and able to adaptable to change to support the business objectives.
- Able to work with the minimum of supervision on own initiative.
- Attention to detail.
- Able to adhere to and communicate the company values.
- A good team player with a sense of humour.
- Jobholder must have ethical standards and uphold company values.
- Must have a fair-minded attitude.
- Able to mentor and develop skills in others.
- Commitment to continual personal development.
- Commitment to maintaining safe Health and Safety practices within the company and department environment.
The Rewards and the Benefits
- Permanent job.
- Competitive salary.
- Regional employer of choice.