Job title:
Regulatory Affairs Officer - Drug Delivery - Lancs - £35-40k

Job description:
A multinational organisation specialising in Drug Delivery Medical Devices are seeking a Senior Regulatory Affairs Officer to join their growing team based in Lancashire. This is a new position which is a result of exponential growth. This is an incredible opportunity for you to come on board and put your stamp on the Regulatory side of the business organisation and shape the role how you see fit. The company has a low turnover owing to a an enjoyable working environment and the culture of heavily investing in your development and progression. Reporting to theQA/RA Director, the Regulatory Affairs Officer will have the following roles and responsibilities: * Preparing regulatory registration, notification, and pre-market submission requirements, including the necessary regulatory documents * Ensures compliance with regulatory agency regulations and interpretations * Creation and submission of Drug Master Files (DMF's) * Providing regulatory support for product changes/modifications, labelling, and promotional material review and approval * Supporting strategic planning and product development efforts * Managing product life cycle from pre-market to post-marking phase, including reviewing and approving promotional material in compliance with corporate and government requirements * Maintains and archives all regulatory documentation * Providing regulatory guidance to local business partners and liaising with RA teams The successful candidate will ideally have: * Knowledge of FDA Regulations and CE Marking Requirements * Experience of Medical Device Directive 93/42/EC * Working knowledge of ISO9001 &ISO13485 * Project management skills If this is something that could be of interest to yourself, apply now!...

Employer Name: Technojobs

Job short description: Electrical engineering technicians

Country: United Kingdom

Region: Lancashire

Contract duration: Permanent

Contract type: Full time

Source of job offer:
Department for Work and Pensions, Public Employment Services, United Kingdom

How to apply: Other - see free text

Salary currency: GBP

Salary period: Monthly