ESSENTIAL: Regulatory affairs. Quality Assurance. Dossier registration. Technical files. Labelling. Auditing.
Medical devices range from small to large, from life enhancing to life saving, all of which need to be stringently regulated to prevent adverse effects to the user. My client, a world leader in the supply of medical devices is currently seeking a Senior Regulatory Affairs Submissions Specialist to join their expanding and diverse team. The role will follow the regulatory strategy for assigned corporate projects and write, file and obtain approvals for international regulatory submissions to their device portfolio.
This role will work across Africa, Turkey the Middle East and India.
Senior Regulatory Affairs Specialist Key Responsibilities:
- Complies with the regulatory requirements and international standards within the region.
- Prepares registration dossiers for approval in EU, Africa and Central Eurasia
- Initiates IFUs and required product labelling in line with relevant EU, Africa and Central Eurasia requirements.
- Prepares Technical Files for CE approval.
- Maintains ISO 13485 certification
- Reviews and approves product labelling.
- Liaises with Competent Authorities and Ministries of health within the region
- Provides input to Regulatory Affairs Impact Documents (RAIDS) from an EU, Africa and Central Eurasia perspective.
- Maintains good visibility of Distributers processes and importation requirements
- Proactively acts as a resource to the regions on RA / QA issues and proposes changes to minimise risks and enhance quality, reliability, safety and productivity.
- Performs audits on 3rd party distributers in the EU, Africa and Central EurasiaSenior Regulatory Affairs Specialist Key Responsibilities:
- Bachelor’s degree in a scientific or technical discipline and 2+ years working knowledge of medical device regulations.
- Understanding of ISO 13485 requirements and EU medical device regulations.
- Ability to read and understand technical material, with the addition of auditing experience.
- Excellent attention to detail & organization skills, with outstanding written and verbal communication skills.
- Computer literate, with intermediate skill in the use of Word, Excel and Outlook, and some knowledge of relational database systems, e.g. Agile Project Management system.
- Experienced at reviewing and approving product labelling.
- Flexible and able to self-manage multiple priorities.
- Flexibility to work across the UK sites, full UK driving license.
This exciting role is available on a 12 month contractual basis and is due to start immediately. If successful you can expect an extremely competitive salary package from a company that truly values work-life balance of its employees, in addition to gaining fantastic experience at a world leading medical device company.
Please call Charles on 01619427163 for more details on rates and applying,