|Location: England||Salary: £40000 - £45000 per annum + Remote working|
|Sector: Medical Devices||Type: Permanent|
|Contact: Simon Douthwaite||Job Published: 23 days ago|
Regulatory Project Manager
Working from home or from the Laboratory offices in Hampshire as a Regulatory Project Manager for one of the UK's most successful contract Labs organisations. We have a great opportunity for someone who has the following experience and education, you will need a background in Pharma, Medical or Science.
Full time, permanent job working from Home with monthly visits to the offices in Hampshire, England.
Knowledge Skills and Abilities
Excellent oral and written communication skills
Must be proficient with Microsoft Office including the ability to develop MS PowerPoint presentations and Excel spreadsheets (including data manipulation and graphing).
Project management, technical writing, and analytical skills.
Bachelor's degree in a scientific or technical discipline, such as Life Sciences.
Working knowledge of medical device regulations, with formal education in regulatory discipline preferred.
A minimum of 2 years' experience in regulatory requirements, e. g. MDD (93/42/EEC) and other related requirements
Experience of a regulated GMP/GLP environment would also be advantageous.
Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
Sound knowledge in product, technology, quality or other related standards
Assessment of Technical Documentation: Perform conformity assessments of regulatory submissions such as Design Dossiers and Technical Documentations to relevant safety principles and standard requirements.
Project Management: Provide project management for customers. Project management potentially consists of issuing quotes, coordinating multiple projects, and answering client questions.
To work in compliance with GLP, GMP and the policies and procedures of Wickham Laboratories Quality System.
Salary - A compeitive salary will be offered for the regulatory project manager, you will be able to work from home remotely with monthly visits to the office Laboratorys.
Services advertised by Gold Group are those of an Agency and/or an Employment Business.