Regulatory Affairs Scientist

VQ Life Sciences are recruiting for a Regulatory Affairs Scientist based in North Wales.

This is an office based position reporting directly to the Quality Manager, you will assist in the day to day running of regulatory affairs whilst providing medical information to customers.

Key responsibilities will include:

• Review raw materials for compliance with EU legislation and standards.
• Maintenance of raw material chemical data base
• Assisting in regulatory affairs activities including REACH compliance
• Complete customer product safety questionnaires
• Prepare and distribute product biocompatibility data sheets.
• Quality compliance - assisting with the quality management of site regulatory requirements
• Review and write SOP's, CAPA's, risk assessments and change control documentation.
• Monitor New Product Introduction progress ensuring quality requirements are met
• Maintenance of job files storage and archival
• Continuous improvement work
• Assisting with the preparation of audits/inspections

Key requirements:

• Degree in Chemistry or other relevant scientific degree
• 5 years working in the medical industry in a regulatory role
• Interpretation of ISO9001(2015) and ISO13485(2016)
• Understanding of regulatory requirements in medical device industry, including the EU Regulations for medical devices (MDR)
• REACH regulations and compliance requirements
• Risk Analysis ISO 31000(2018)
• Quality Management
• Excellent attention to detail
• Strong communication, interpersonal and presentation skills
• Self-motivated, can multi-task and work to strict deadlines
• React quickly to situations whilst keeping calm under pressure
• Computer literate

This positive is for a passionate individual who has a real hunger to succeed and develop. This is for someone who can innovate, collaborate, problem-solve and develop themselves.

If you have recent Regulatory Affairs experience within the Medical Device industry and interested in this position in North Wales please get in touch.