Verification and Compliance Engineer

Job Purpose

Work as part of the R&D Engineering team on new and legacy medical devices, ensuring compliance with internationally recognized standards.

Key Duties/Responsibilities & Functions

Degree qualified in a Sciences or Engineering discipline Responsible for identification, interpretation and compliance to standards & regulations including IEC60601-1 Part 1 and Part 2 standards, ISO10993-1, ISO14971.

Work as part of the R&D Engineering team on new and legacy medical devices, ensuring compliance with internationally recognized standards.

Preparation of medical device applications and data packages for the regulatory authorities. •   Liaising with authorities, regulatory bodies and test agencies, as appropriate, to fulfil your responsibilities.

Monitor new and revised versions of Technical standards/regulation.

Perform GAP analyses, facilitate impact assessments and distribute into all projects.

Produce and support clear and concise rationales to support the Technical impact assessments.

Assists in preparation for and participation in regulatory agency audits.

Updates, reviews and assists in departmental procedures, policies as required.

Perform other duties as assigned by the line manager.

Knowledge, Skills & Experience

Qualified to degree level in an Engineering or Science discipline.

2 or more years’ experience working with international medical device testing bodies, regulations and standards.

Expertise in the area of Technical standards and regulations (Product / technology / state of the art).

Experience of interaction with test agencies and regulatory bodies.

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.

Personal Qualities

Approaches problems with a can do attitude, able to think out of the box and multi-task •   Must have the ability to understand and generate complex documentation.

Ability to coordinate, facilitate and work well in cross-functional teams.

Good team player and able to communicate at all levels and across disciplines in verbal and written form

What We Will Offer in Return

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.

Why Diversity Matters To Us

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.

Where You Make a Difference

To us it matters not only what we do, but also how we do it. There are four components of our culture: 

Diversity & Inclusion – we view diversity as a driver of innovation & a catalyst for our global growth

Winning as a team – where members of our team are empowered to make decisions at the right level

Leadership style – being visible, connecting with others and leading by example

Our core values – Passion, Collaboration, Openness, Ownership & Excellence

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

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.