To support product registration activities and product registration submissions throughout the world, in order that registrations are achieved in a timely manner in accordance with regulatory and Company requirements
- Provide full support to all registration activities and regulatory submissions throughout the world.
- Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
- Maintain information on worldwide regulatory requirements and the status of product registrations.
- Liaise with all departments and project teams to co-ordinate timely applications for regulatory approvals.
- To be aware of progress and developments of worldwide regulatory requirements.
- To follow and promote Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results.
Qualifications And Experience:
- A good first degree in a relevant scientific discipline, or equivalent.
- Significant regulatory experience covering medical devices.
- Commanding knowledge of worldwide regulatory procedures, especially for medical devices.
- Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements
- Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
- Possess computer competency in Microsoft office software, data collection and general analysis tools.
- Excellent PC skills (Microsoft Office Package).
- Excellent written and verbal reasoning skills.
- Excellent planning and organisational skills.
- Communication - listener, learner and thinker.
- Product awareness and thorough knowledge of respective regulatory frameworks.
- Thorough and flexible.
- Cross culturally aware.
- Team player
- Enthusiastic and committed.
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