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 government institutions worldwide, at central and region/state levels, the private healthcare sector, and some of the largest private sector corporations on the global stage: MacDonald’s, Costco, Amazon, Walmart, Rolls Royce 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
We are looking for a Data Analyst to join our growing global medical device Quality and Regulatory team to support with Regulatory activities. 2San is a global distributor of medical device products falling broadly into three categories: Clean, Protect, Test. We are maintaining a Global ISO 9001:2015 Quality Management System and working towards ISO 13485 certification for a sub-division of the business.
The role will be to support the Regulatory function with: Post Market Surveillance, data, analysis and scheduling of in-market regulatory commitments. To maintain accurate documented procedures and support contributing stakeholders in the execution of these procedures.
The team is led by an SLT member within the organisation (Global Head of Quality & Regulatory), supported by local jurisdictional experts in-region, and act as a central function to coordinate and oversee Quality Assurance and Regulatory activities across the Regions.
KEY ACCOUNTABILITIES/RESPONSIBILITIES
- Strategy
- Key Accountabilities / Responsibilities:
- Support the Quality & Regulatory Strategy by suitable priotitisation of activities, timely response to time-critical activities, and thorough documentation of essential evidence and key decisions within the quality management system.
- Measures of Success :
- KPIs on dashboard remain on track
- Operations
- Key Accountabilities / Responsibilities
- Coordinate post market surveillance activities where applicable.
- Receive and analyse feedback data from sources globally, e.g. amazon reviews, retailer reports, complaints system
- Ensure good documentation practices and data integrity principles throughout the organisation.
- Maintain and issue GTINs within the system for product management.
- Track and Schedule regulatory commitments across jurisdictions.
- Measures of Success
- Regulatory commitments remain on time with no late notices issued
- Internal audits of the processes responsible for show no major findings.
- Activities completed within timelines stipulated in SOPs and task board.
- Leadership
- Key Accountabilities / Responsibilities
- Demonstrate the quality objectives in all activities and liaison with the wider business functions
- Measures of Success :
- Lead by example and influence others
KEY SKILLS & EXPERIENCE
- Experience with data base searches, creating reports from data, and gathering information advantageousPrevious experience of a regulated environment desirable
- Willingness to learn and initiative to set own tasks from central team list required
- Knowledge of the 510(k) FDA application process advantageous
- Excellent organizational and time-management skills
- Strong attention to detail and accuracy in task execution
- Effective communication skills for collaboration with internal teams and external stakeholders
- Familiarity with relevant software tools and systems, such as MS Office, Orderwise and Job Logic
- Ability to multitask and prioritize tasks based on urgency and importance
PERSON SPECIFICATION
Technical Expertise
· A relevant bachelor’s degree, or equivalent professional qualification.
· A minimum of 3 years post qualified experience in a similar role, preferably within a start-up or scale up environment.
OR
· A minimum of 6 years recent experience in a similar role, preferably within a start-up or scale up environment.
AND
· Significant executive support experience
· Proficient in the use of the MS Office suite
· Experience within a fast-paced and high energy environment
· An aptitude for executing business improvement initiatives.
· 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
· Experience in a global business environment
· Experience in a start-up environment.
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
Circumstances & Compensation
- Fluent in English (C2 or above)
- Must be eligible to work in UK time zone
- Location: Remote, work from home
- Compensation: 50,000 PHP per month
- Perks & Benefits: Work from home, Paid training and ongoing learning & development courses, Access to 2San’s EapAssist Employee Program, Centr Fitness App and Wellness Subscription, Birthday Cake, Monthly Game Prize, 13th Month Pay, Annual PHP get together event, Annual Job Review and Contract Renewal
- We believe in looking after the people who power our business. That’s why we give everyone who joins access to Perkbox. It’s part of our commitment to look after you beyond just the pay packet. A Perkbox account gives you 24/7 access to perks, benefits, discounts, wellbeing tools and loads more!
Technology Setup
In addition to the above, you must also have the appropriate technology system & software in place as below:
- Internet not lower than 50 MBPS
- Less than 3 year old Laptop or PC with at least Intel Core i3 processor and 4GB RAM (or equivalent)
- Noise cancellation headset & a webcam
CompensationPHP 40,000 per month