Regulatory Officer – Temporary£30.00 per hour
To support the business in the development and commercialisation of a range of pharmaceutical drug and medical device products.
This will include membership of development and commercialisation teams providing regulatory advice on new product development and product change. Responsibility for estimation and monitoring of regulatory resource requirements.
Key Skills, Qualifications, Attributes and Capabilities:
Proven project planning skills
Strong written and verbal communication skills.
Highly developed interpersonal and team skills with experience of dealing with external customers.
Strategic thinker who can deliver regulatory solutions.
Easily adaptive to change and new circumstances.
Able to handle multiple and complex tasks and be comfortable getting involved in detailed regulatory work as well as understand the bigger picture.
Capable of understanding the business needs and priorities and translating these into appropriate regulatory actions.
Strong IT skills.
At least 5 years regulatory experience, including drug and device registration globally.
Experience in CE marking, including writing Technical Dossiers for complex medical devices which use electronics and software/firmware
Experience in Registration of Drug/Device combination products including device clearance.
Global experience in App development and 510(K) applications.
Bachelors degree in Science.