Job Location: Basingstoke or Macclesfield Office
Who we are?
Healthcare 21 is a sales, marketing, and technical services company. Our purpose is to deliver products and solutions to assist healthcare providers achieve optimum clinical outcomes. We are a high growth company that aims to be the partner of choice for our global healthcare suppliers; deliver on our promises to our customers across hospitals and the wider community; and promote ownership within our employees to be the best at everything they do.
We are a values-based company who recognise and reward employees that embrace our values of passion, innovation, transparency, and simplicity. We are respectful of others and do not accept discrimination in any form. We believe it is our differences that are essential in forming our effective and creative teams and it has made us the sustainable business that we are today.
The long-term success of our sustainable business is based on our teamwork, integrity, and the ability of our people to take ownership of their role. It is our responsibility to provide you with an exciting, innovative environment that is respectful, fulfilling and rewarding.
Job snapshot
In this role, you will oversee the complete range of Quality, Compliance, and Regulatory activities within the HC21 Group. Your primary responsibility will be ensuring the organization's adherence to industry standards, regulations, and internal procedures, maintaining exceptional levels of quality and compliance. With a strong focus on continuous improvement and proactive problem-solving, you will demonstrate a flexible approach to your responsibilities. Additionally, you will collaborate closely with teams across the organization—such as Commercial, Customer Service, and Warehouse—to meet regulatory requirements while supporting business growth and innovation.
Key Responsibilities & Competencies:
1. Quality Control:
Implementing and monitoring quality assurance processes to ensure that products or services meet the required standards. Example:
o Oversee the entire product complaint process, from the initial complaint to the receipt of a closure letter, ensuring proper documentation in the product complaints log and effective communication with relevant departments and regulatory bodies.
o Assist with product recalls and notifications, keeping an updated control sheet, and ensuring communication of Field Safety Notices to the appropriate departments and regulatory bodies.
o Analyse complaint trends, identifying any serious risks, and report or escalate findings as necessary.
2. Compliance Monitoring:
Ensuring the company complies with legal, regulatory, and industry standards, such as ISOs, UK MDR, EU MDR, Defra Regs (Waste Management), GDPR, Modern Slavery, and other specific certifications.
o Review and update regulatory procedures across the Healthcare 21 Group to ensure compliance.
o Ensure products and suppliers adhere to UK legislation, UK MDR, Ethical Business Practices, and other relevant requirements.
o Approve or support sponsorship, grants, and training requests in accordance with the ABHI Code of Business Practice.
o Manage UKRP (UK Responsible Person) responsibilities and support Supplier Management Activities.
o Support stakeholders with the administrative, training, monitoring, risk assessing, communication and general operational and supply chain controls needed to be compliant with the Anti-Modern Slavery Policy, the ILO’s Ethical Trading Initiatives’ base code and specifically the Labour Standards Assurance System (UK) requirements for NHS Supply Chain compliance.
3. Documentation and Reporting:
Managing and maintaining accurate documentation of quality and compliance processes, audits, and any corrective actions taken. Example:
o Recording KPI reviews, quality activities, and minutes from Quality meetings.
o Reviewing and updating Standard Operating Procedures (SOPs) regularly.
o Ensuring that any quality issues are promptly reported and addressed in accordance with internal processes.
o Identifying and mitigating risks related to non-compliance or quality control failures, utilizing Risk Management tools to prevent or minimize compliance breaches.
4. Collaboration:
Working closely with different departments, such as operations, service and HR to ensure quality and compliance objectives are met across the organization and all sustainability initiatives are effectively implemented. Example:
o Oversee the timely correction of all audit deficiencies and maintain effective workflow processes for change control, deviation, CAPAs, complaints etc.
o Assist departments in reviewing and improving processes, standards and delivery of specific projects as required.
o Ensure the timely and accurate submission of the GB sustainability metrics, support data collection and reporting process.
o Cooperate with other departments to integrate sustainable practices into day-to-day business processes focusing on reducing the organization’s environmental impact and promoting social responsibility.
5. Training and Development:
Educating employees on quality management systems, compliance regulations, sustainability and best practices and ensuring the QMS training records are kept up to date.
6. Audits, Testing and Online Assessments:
Conducting internal audits to identify any gaps in compliance and recommend improvements. Participate and assist in the successful completion of external audits, including suppliers’, ISOs’, Modern Slavery, Compliance Schemes’, online assessments eg. MSAT, DSP Toolkit and BCP testing.
7. Problem-Solving: Addressing non-compliance issues and work alongside other departments to implement solutions.
8. Continuous Improvement: Suggesting and implementing process improvements to enhance quality and sustainability and ensure compliance with evolving standards / regulations.
9. Other: Perform any other ad-hoc duties as required by Management.
Key Requirements
1. A background in Regulatory and/or Compliance.
2. Ability to review legislation and regulations and translate them into company processes.
3. Experience working as part of a project group or with project management.
4. High level of computer literacy including proficiency in Microsoft Office.
5. Experience of working in a fast-paced environment.
6. Experience working with Quality Management Systems, ISO standards and MHRA regulations including ISO 9001, ISO13485, ISO27001.
7. Experience in dealing with regulatory bodies is an advantage.
8. Experience working in a Medical Device company is a distinct advantage.
9. Knowledge of Environment standards (ISO14001) is an advantage.
10. Experience with Occupational Health and Safety standards (ISO45001) is a plus.
11. Regulatory Knowledge.
12. Attention to Details.
13. Risk Management.
14. Audit and Inspection experience.
15. Problem-Solving and Decision-Making.
16. Project Management.
17. Data Analysis and Reporting.
18. Knowledge of Quality and Environmental Management Systems.
19. Interpersonal and Communication Skills.
20. Ethical Standards and Integrity.
21. Adaptability and Learning Agility.
22. Teamwork and Collaboration.
What are some of the benefits of working at Healthcare 21?
* HC21 training academy.
* Savings & Cycle Schemes.
* Remote/Flexible Working.
* Salary and bonus structures.
* Sustainable business strategy.
* Employee Assistance Programme.
* Pension, life assurance & income protection.
* Long service awards & employee of the month.
* Employee events & initiatives all throughout the year.
* Enhanced sick pay scheme that increases with service.
* Enhanced annual and life leave that increases with service.
We are proud to be an equal opportunity employer. At Healthcare 21 we know that diversity makes us stronger. We are committed to a collaborative, inclusive environment. We strive for everyone to feel valued, connected and empowered to reach their potential and contribute their best.
We also know the confidence gap can often get in the way of meeting spectacular candidates, so please don’t hesitate to apply — we’d love to hear from you!
#J-18808-Ljbffr