Regulatory Project Manager
Working hours are 37.5 per week. Option to work from home for approximately 50% of the time.
Responsibilities:
- 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
Knowledge Skills and Experience Required:
- Bachelor’s degree in a scientific or technical discipline, such as Life Sciences
- A minimum of 2 years’ experience in regulatory requirements, e.g. MDD (93/42/EEC) and other related requirements
- Working knowledge of medical device regulations, with formal education in regulatory discipline preferred
- Technical writing experience with experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
- Sound knowledge in product, technology, quality or other related standards
- 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
- Experience of a regulated GMP/GLP environment would also be advantageous.
Salary Reward and Package:
- Salary dependent on qualifications and experience
- Extra days holiday for continuous service, day off on your birthday & option to buy additional holiday
- Private medical insurance
- Mobile phone
- Auto enrolment pension scheme
- Life assurance
- Medical cash back scheme (after probation)
- Bike to work scheme
Please apply with your CV via hr@wickhamlabs.co.uk
Wickham Laboratories Limited is an Equal Opportunities Employer.
