Title: Regulatory Affairs Associate
Job Type: Full time permanent
Salary: £30,000 - £40,000 per annum
Contact Person: Miss Selina Thompson
Opportunity: Are you currently working in medical device regulatory affairs? Have you compiled Technical Files for CE Markings? Have you prepared dossiers for FDA submissions? Want to work for an innovative manufacturing company with great career development? If yes then please read on.
Your role as a Regulatory Affairs Associate based in Loughborough will involve working with Class 1, Class 2 and Class 3 medical devices preparing regulatory submissions for global product registrations / approvals for new products / line extensions.
You will be working on new medical device products to ensure the appropriate licensing, marketing and legal compliance of the company’s medical device products and activities.
Other duties include:
This is a full time permanent job opportunity paying an excellent salary between £30,000 - £40,000 per annum dependent on skills and experience and excellent benefits.
- Producing medical device Design Dossiers, Technical Files and Device Master Files for CE marking approval.
- Preparing dossiers for FDA submissions.
- Preparation of regulatory submissions for global product registrations / approvals for new products / line extensions.
- Updating and reviewing of IFUs, packaging, patient information leaflets, labelling and marketing literature for medical device products.
- Maintaining and developing on quality systems such as GMP, ISO 9001 and ISO 13485.
- Quality assurance.
Skills: To apply for the role of Regulatory Affairs Associate you will have:
- Several years medical device regulatory affairs experience.
- Experience in compiling Technical Files for CE Marking approval.
- Experience in preparing dossiers for FDA submissions.
- Experience of working with quality systems e.g. ISO 13485, GMP and ISO 9001.