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.
COMPANY OVERVIEW
We believe in Excellence, Integrity, Agility, Rigor and Fearlessness. To consistently deliver on our promise of “Better care. Better life”, these five core values form the bedrock of our identity, culture and success. They give us a common purpose and we all collectively understand them, work towards them and live by them every day.
2San is a leading global distributor designing and delivering an expanding range of products and solutions that fit into three core categories: Clean, Protect and Test.
We’ve grown rapidly into an industry ‘disruptor’ in our own right by championing innovative products and solutions that seek to deliver better care, better life. We advocate for the movement that empowers people to own their own health and make informed decisions about it.
As a partner of choice, 2San’s client-base has spans federal and state governments worldwide, the private healthcare sector, and some of the largest retailers: MacDonald’s, Costco, Amazon, Walmart, CVS, and the Woolworths Group, to name but a few.
We have ambitious plans for our future and as a valued member of our team we look to you to share in, and embody, our vision – to make our journey your journey. We’re invested in you, and dedicated to fostering a vibrant culture that develops your skills, nurtures your potential, and stimulates your professional growth for a lasting career with us.
This job profile will not remain static as you will be empowered to map out your own trajectory and showcase your abilities to ensure you reach potential and thrive.
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
- 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
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
PERSON SPECIFICATION
Technical Expertise
- A science-based bachelor’s degree, or equivalent professional qualification.
- Proficient in the use of the MS Office suite
- Experience within a fast-paced and high energy environment
- Experience of troubleshooting problems and providing recommendations.
- Ability to react with appropriate levels of urgency to situations and events that require quick response or turnaround.
- Able to maintain a high level of integrity and discretion in handling confidential information.
- Excellent judgment is essential.
- Ability to switch gears at a moment’s notice.
- You’re an expert juggler; managing and juggling multiple projects simultaneously
- An aptitude for executing business improvement initiatives.
Special Aptitudes
- High-impact communication skills with the ability to influence
- Ability to nurture collaborative relations
- Relentless focus on stakeholder needs and service excellence
- Ability to work under pressure with a positive “can do” attitude
- Superb time management, analytical, decision-making, and problem-solving skills.
- Proactive and agile work ethic
