Description
Major Responsibilities:- Formulate, develop and implement a program to enable all CE marking registrations are completed efficiently and to an agreed schedule
- Support a roll out program for existing products and new launches
- Work with the RA colleagues around the world to ensure clear communication of requirements to meet timely worldwide registration
- Implement the creation and development of Technical files and Design Dossiers to meet the requirements of the Medical Devices Directive and guidance documents.
- Review all baseline and translated (new and on-market) labelling marketing and training materials for regulatory compliance within EU Member States. Where appropriate ensure regulatory compliance is met for those countries outside of the EU.
- Provide timely guidance and support to project development teams to ensure project development and documentation will meet the regulatory requirements in target countries.
- Undertake specific projects as assigned by the line manager to the agreed timescales.
- Ensure that all documentation is correctly completed to a high standard of clarity.
- Maintain awareness of regulations and guidelines governing the company and communicate their impact on the registrations.
- To open and maintain regular communications with any contacts requiring any regulatory involvement.
- Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Corporate requirements and applicable regulation
- Maintain awareness and ensure compliance with site EHS policy and procedure
Education:
Educated to degree level or equivalent preferably in a scientific or engineering discipline e.g. or bioengineering etc. with minimum two to four years of regulatory submissions experience in Medical Device Directives.
Background:
Knowledge of regulatory requirements for ISO 13485, MDD (93/42/EEC) and FDA Quality Systems Regulations would be advantageous but dependent on background and experience, not essential. Experience within a medical or healthcare manufacturing industry preferably in a regulatory role. Good written and oral skills, good interpersonal skills and an ability to work on their own initiative and as part of a multi-disciplinary team. Good organisational skills, an ability to work under pressure and communicate effectively with people at all levels throughout the organisation.
The above background prerequisites are required to provide a level of knowledge and experience to complete registrations and associated duties.