You will be responsible for compiling and maintaining technical files, the preparation and submission of global regulatory documents and providing regulatory compliance guidance.
This role will require working with internal functional teams, competent authorities, and international regulatory agencies.
What are my responsibilities?
- Manage the creation, development and maintenance of Technical Files
- Management of product and process risk analysis.
- Plan and co-ordinate product verification and validation activities/programs.
- Provide regulatory guidance to internal teams in the planning of new product development and changes to existing products and processes
- Work with your line manager to maintain device licences and authorisations for existing products.
- Review labelling, marketing and training materials for regulatory compliance.
- Provide regulatory support during internal and external audits.
What you'll need to succeed
- Degree in scientific or engineering discipline preferred. It will be highly advantageous if a candidate has previously worked within the biomedical industry.
- Quality assurance and regulatory affairs experience ideally gained within the medical device, pharmaceutical or electrical/electronic product industry
- Familiar with ISO 13485, FDA 21 CFR 820, ISO 14971 and MDR 2017/745 requirements
- Good level of IT literacy, including MS Word and Excel
- Good verbal and written communication skills and attention to detail
- Self-motivated, results-oriented with an ability to resolve problems effectively and efficiently.
- Willingness to learn and get involved in a variety of tasks