Description
My client specialises in Diagnostic Medical Devices and is now looking for a Senior Regulatory Affairs Officer to act as the businesses Regulatory expert. The role will include working with a team of trained part-time auditors to carry out and report on the internal audits according to agreed schedules.The main responsibilities of the role are:
- Preparation and submission of European (CE) and FDA applications for the authorisation to market new products in Europe and USA. Support with relevant tests and documentations for all regulatory filings for existing and new products through third parties or our own local regulatory personnel for product registrations in Easter Europe, China, South America, Fare East Asia and other territories.
- Maintaining excellent relationship with Medicine and Healthcare products Regulatory Agency (MRHA) and other regulatory and notified bodies and dealing with issues relating to products life cycle, risk assessment and other business processes.
- Organisation and management of external regulatory audit as an when necessary.
- Monitoring Internal Quality, testing and Engineering staff as well as external advisors and test house staff when assigned or contracted to handle regulatory work such as CAPA, Product testing, Field reports and performance analysis, etc.
- Maintenance and continuous improvement of the "Quality and compliance Management System" to ensure efficient compliance with ISO 13485, FDA regulation 21CFR and other international regulations applicable to a globally growing manufacturing business.
- Planning and carrying out internal audits (through a team of part-time internal trained auditors) on all areas of the business to ensure compliance with the relevant ISO, FDA and other international standards and regulatory authorities and notify body requirements.
- Maintaining product specification, packaging information and master labelling data which would enable product shipments to various regions complying with all local rules and regulations.
Essential Requirements:
- Educated to degree level in a science or engineering subject (2:1).
- Capable of multi project management and ability to handle elastic work load.
- Substantial experience in the medical device manufacturing and healthcare industry
- Good understanding of ISO13485, ISO9000 and FDA regulatory requirements and hands-on experience of application of CAPA within the medical devices sector.
- Good understanding of FDA regulations, experience of Good Manufacturing Practices, and experience of dealing with MRHA and other notified bodies.
- Experienced Auditor of Quality Management Systems for ISO and FDA 21CFR part 820.
- Excellent analytical skills and experience of analysing device related field data and handling of CAPA , Device History Records, Risk Assessments and continuous product monitoring and controlled product change and improvement processes.
- Experience of reading and interpreting scientific and academic papers and international standards. Excellent communication and report writing skills.
- Experience of contribution to New Product Development projects, and successful track record of application processing for CE and FDA 510K for new product introduction
If you believe you have the correct experience then please send me your CV and I will be in touch shortly.
To find out more about Real please visit www.realstaffing.com