Quality and Regulatory Graduate Program

at  2San

POSITION DETAILS

• Position Title: Quality and Regulatory Graduate Program
• Effective Date: 01 June 2025
• Reports To: Jessica Austin – Global Quality Specialist
• Laptop & equipment provided.
• 21 Days holiday + bank holidays.
• As a global company, travel opportunities arise.
• 35 hrs / week (exclusive of a 1hr lunch break)The standard working hours are Monday - Friday 9:00am - 5:00pm.

KEY SKILLS & EXPERIENCE

• Recent graduate from a science-based degree such as Biology, Biomedical Sciences, Chemistry, Health and Life Sciences
• Pro-active and inquisitive individual who is always striving to learn and develop their personal skills
• Experience in a start-up or fast-moving business environment is advantageous
• An interest in the medical device industry
• Experience of working in a remote environment with the ability to plan, prioitise tasks and adapt to urgencies and unexpected tasks
• Ability to comprehend global standards such as ISO 9001 and ISO 13485 along with regulations such as IVDR e.g. research experience
• Knowledge of Good documentation practices and understanding of how to follow these
• Experience of quality management systems is advantageous

ROLE OVERVIEW

The Global Quality and Regulatory department have a two-year graduate program available for all science-based graduates, which is 6-month rotations between the three positions listed below with the option to choose your preferred area for the last 6 months of the program.

• Global Quality Document Controller
• Legal Manufacturer Quality Post-Market Surveillance
• Regulatory Design and Development Coordinator

KEY ACCOUNTABILITIES/RESPONSIBILITIES

• Global Quality Document Controller (Graduate)
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• Writing Standard Operating Procedures (SOPs)

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• eQMS actions including Document management, Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPAs)

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• Coordination of cross-functional quality training

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• Designing workflows using MS Visio

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• Group mailbox management

• Legal Manufacturer Quality Post-Market Surveillance (Graduate)
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• Complaint and Feedback Assessment including customer surveys and focus groups

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• Reporting to Regulatory Authorities

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• Trending activity and management information (KPIs)

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• Pro-active literature reviews

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• Development of existing 2San App for Post-Market Surveillance Activity (PMS)

• Regulatory Design and Development Coordinator (Graduate)
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• Project management and Design Control Committee Coordination

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• Clinical data review and design file creation

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• Collaboration on product development

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• Regulatory pathway research

• eQMS actions including change controls and batch release