Huntleigh welcomes people from all backgrounds and walks of life, we believe that a culture of equality, diversity and inclusion not only benefits our organisation but supports wellbeing. As a proud member of the Arjo family, we share a passion in helping people improve their lives and believe that great healthcare is always a collective effort.

Responsible for identification, monitoring, interpretation of global product compliance standards/regulations including IEC60601-1 Part 1 and Part 2 standards.

Facilitate and drive the change control process of standards and drive communication and knowledge exchange regarding impact assessment.

Responsible for contact with Test Laboratories and providing input to projects with certification strategy for testing in Test Laboratories.         

• Work as part of the Engineering team in relation to all products (NMI and Maintenance).
• Identify, monitor new and revised versions of standards/regulations within scope.
• Maintain procedures for monitoring of standards/regulations (LIS-007 and SOP-043).
• Perform GAP analyses and facilitate impact assessments and distribute into all projects.
• Communicate knowledge exchange regarding impact assessments, providing general guidance on how to interpret standards and regulations.
• Produce and support clear and concise rationales to support the impact assessments.
• Drive the Track Wise process for new/revised standards and regulations including follow up on implementation of changes.
• Coordinate regulatory key processes requiring certified testing by a test house / certified body.
• Supporting contact with test agencies.

Audits, QMS & CAPAs:

• Assists in preparation for and participate in regulatory agency audits.
• Updates, reviews and assists in departmental procedures, policies as required.

Other:

• Perform other duties as assigned by the line manager.

 Quality System Duties and Responsibilities:

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
  

Required Knowledge/Skills/Experience:

• Experience of working with international medical device regulations and registration.
• Expertise in the area of standards and regulations (Product / technology / state of the art).
• Knowledge of coordination with test agencies and surveillance of certifications.
• Must be able to interpret information in standards and rationalise for use by Engineers.
• Conversant in Microsoft Word and Excel.
• Excellent written and verbal communication skills in English.
  

• Must have the ability to understand and generate complex documentation.
• Ability to coordinate, facilitate and work well in cross-functional teams.
• Must be able to provide clear and accurate judgements.
• Must be able to manage projects systematically.

• None.

You will support our vision that great healthcare is always a collective first. In return, we recognise and value our global employees. You will have our full support, training and opportunities for professional development, along with a competitive package.

At Huntleigh Healthcare, we believe in the power of diversity. We strongly encourage applicants from all parts of society, which means building a more diverse, equitable, inclusive and engaging environment – not only in the workplace, but also within the communities that we serve, work in and live in. We achieve this through a culture and mindset that values the uniqueness of all our people.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Please be aware that by applying for this role, you are giving Huntleigh Healthcare/Arjo permission to store your information.