Regulatory Affairs Specialist

 You will be responsible for overseeing a portfolio of products within the AWC business unit and all aspects of their management this can include: 

• Managing project and regulatory involvement with direct management supervision. This includes providing on-going regulatory advice to project teams throughout the product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.

• To compile and review, as required, regulatory submissions in accordance with national requirements to ensure appropriateness and consistency in content and presentation of information both within and between registration applications. This can include European Technical Files, US 510(k) applications and device listings as required.

• To complete the requirements of the Smith & Nephew regulatory submission plan per the requirements of RIMSYS (recording/tracking of regulatory submission application).

• To review and approve artwork, labelling and promotional literature and advise on its acceptability/compliance with regulations and registered details.

• To review and approve change control impact assessments for products.