£120 - £170 per day
6 months ago
- Interim Quality Assurance Specialist - £120-170p/d
An Interim Quality Assurance Specialist at £120-170p/d is required for a unique specialist manufacturing organisation who are the world leaders in their field, and a rapidly expanding FTSE100 organisation. A 12 month initial contract in Warwickshire, likely to extend, and providing long term stability, this is an exciting opportunity within Quality Assurance and Regulatory Affairs for a candidate who is looking to develop their experience within a global, diverse and fast-paced function, and a world leading brand.
This Quality Assurance position is responsible for representing the function for all Field Safety Corrective Actions.
- Complete and/or manage Competent Authority reporting activities
- Act as single point of contact with the UK & Ireland Competent Authorities
- Collate and report evidence of FSCA closure for each affected country within EUCAN region.
- Direct non-standard questions to the relevant functions/teams
- Manage Competent Authority expectations and ensure timeliness of responses
- Develop and assist in product registrations & re-registrations, including the supply of necessary documents for Europe and Canada and to existing approved countries for our products.
- Managing and obtaining legalization of documents for our customers.
- Assist in the development, review and implementing regional policies and procedures based on corporate requirements.
- Assist in regulatory aspects of commercial business relationships to ensure compliance
- Assess commercial activities in the EU for compliance and propose and implement potential solutions.
- Minimum 1-2 years experiences in regulatory affairs or quality assurance
- Minimum 3 years Quality Assurance activities related to medical devices or pharmaceuticals
- Proficient in Word and Excel, and good writing skill is needed. Experience in MS Access, MS Visio, Agile, and SAP desirable.