Regulatory Compliance Coordinator

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 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. At Healthcare 21, 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. Want to know more about what to expect from a working life in Healthcare21, then click here.
Your Role at Healthcare 21
You will be required to fulfil the full range of Regulatory & Compliance duties across the Healthcare 21 Group.
You will oversee and manage the compliance program in collaboration with the Quality and Regulatory team. To develop, initiate, maintain, and revise policies and procedures for the general operation of the compliance program and its related activities to prevent illegal or improper conduct
You will have a strong drive for continuous improvement and a flexible approach to all areas of the role and work with multiple stakeholders across the Group, including Commercial, Customer Service, Warehouse and Management

**Job Location**: Stonehouse or Basingstoke, UK
What are the Key responsibilities and activities of a Regulatory Compliance Coordinator;
Manage product complaints, maintain a product complaint control sheet, and communicate details of complaints to the relevant departments and regulatory bodies
Support product recalls / notifications, maintain a product recall / notification control sheet and communicate details of Field Safety Notices to the relevant departments and regulatory bodies
Review and update regulatory procedures across the Healthcare 21 Group
Liaise with Senior Management, Commercial, Customer Service and Warehouse Managers in reviewing and improving processes, standards and delivery of specific projects as required
Assist in the successful completion of Quality audits, including ISO9001 and HPRA audits
Generation of KPIs, reports and minutes for Quality meetings
Ensure product compliance with EU legislation
Assist with organising and recording training regarding the quality system, applicable standards, and regulations across all departments
Conduct internal departmental audits as required
Perform any other ad-hoc duties as required by Management

What are the role requirements?

Regulatory and / or Compliance background desired
Experience working with the following Quality Management Systems would be a distinct advantage:
ISO9001:2015 QMS
ISO13485:2016 QMS

Experience with the following Quality Management Systems would be beneficial

ISO14001:2015 Environmental Management System

**ISO27001**: 2013 Information Security

Experience of working in a fast-paced, highly pressurized environment
High level of computer literacy including a good working knowledge of Microsoft Office
Experience in dealing with regulatory bodies would be an advantage
Experience working in a Medical Device company would be a distinct advantage

Who exceeds in this role?

**Top performers in the position will**:
Handle pressure and work to strict deadlines, while maintaining a strong focus on process-orientated activities
Be capable of dealing with all complaints / issues in a professional, efficient, and confidential manner, ensuring that any non-compliance is immediately acted upon.
Work effectively with all levels of the organisation and utilise a team approach to achieve goals and deliverables
Have strong organisational skills with the ability to multitask, while maintaining excellent attention to detail and accuracy

What are some of the benefits of working at Healthcare 21?

Competitive salary and bonus structure
Employee Assistance Program
Pension, Life assurance
Educational Assistance
HC21 training academy
Enhanced annual and life leave
Employee engagement initiatives and a dedicated internal employee communication platform WorkVivo.

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.