Senior Regulatory Affairs Specialist
|Job Title:||Senior Regulatory Affairs Specialist|
|Location:||Kingston Upon Hull, East Riding of Yorkshire|
|Salary:||£42000 - £45000 per annum|
|Contact Name:||Rachel Radford|
|Job Published:||March 09, 2017 09:34|
Reporting to one of the Senior Regulatory Affairs Managers, the Senior Regulatory Affairs Specialist will work on a variety of regulatory products across a wide range medical devices product portfolio to meet strict product launch dates. You will get exposure to different product lines including the core medical devices and further develop your knowledge of this area.
Key responsibilities include but are not limited to:
- Preparing, reviewing and approving data elements for use in regulatory dossiers in accordance with EU and international requirements for medicinal products/clinical trial clearances.
- Compiling, reviewing and approving, as required, regulatory despatches in accordance with national requirements to ensure appropriateness and consistency in consistency in content and presentation of information both within and between registration applications.
- Deputising for the Regulatory Affairs (RA) Manager, where appropriate and when required.
- Providing on-going regulatory advice to project teams throughout product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.
- Interpreting individual country legislation relevant to the business.
- Providing advice and guidance, in an expert capacity, to the RA staff.
- Liaising with external regulatory authorities to ensure approvals are obtained in line with the launch plan.
- Reviewing and approving artwork, labelling and promotional literature from UK / Group Companies based on acceptability/compliance with regulations/compliance with registered details and in compliance with the Blue Guide as well as advise on its acceptability/compliance with regulations and registered details.
- Maintaining marketing authorisations to account for changes in the product or national legislation requirements and licence renewals.
- Reviewing and approving change control impact assessments for products.
- Performing all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485.
- Applying high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
- An honours degree in a science subject or equivalent
- Substantial regulatory experience within a regulatory compliance function and with a medical devices background
- The ability to be able to multi-task and juggle projects and tasks simultaneously to keep things on track coupled with strong organisational and prioritisation skills is essential to the success of this role.
- Collaboration and team playing skills is key here as well as being able to take ownership for projects and tasks be accountable for their own work.
- Technical Expertise: Must be capable of developing and sharing expert functional knowledge.
If this job is of interest please don't hesitate to apply!
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