Clinical Compliance Engineer

Company Description

Inspiration Healthcare is a British based, global provider of medical technology, and our mission is to pioneer medical technology that improves outcomes of patients, starting with the very first breaths of life.

We provide high-quality, innovative products to patients around the world that help to improve patient outcomes, and we actively invest in innovative product opportunities, disruptive technologies and, of course, our people.

The Group currently consists of three companies: Inspiration Healthcare Ltd, SLE Ltd and Viomedex Ltd and, under these brands, we sell neonatal intensive care and operating theatre equipment around the world through a network of distributors into over 75 countries.

We also offer a full range of ambulatory infusion care devices for both hospital and homecare applications to customers across the UK and Ireland.

Products range from highly sophisticated capital equipment through to single-use disposables all of which can help improve outcomes of extremely sick patients.

We can proudly admit that we haven't come this far without entrepreneurial spirit, a solution driven attitude, and a determination to improve outcomes for premature and sick babies. So if making a positive difference to other people's lives resonates with you and you believe that you have what it takes to flourish and succeed in this role, then we’d love to hear from you.

Position

Job Purpose (Role Definition):

To provide support to the clinical compliance team, who are responsible for undertaking: clinical evaluations, providing support to the Research and Development and Regulatory Affairs and teams in new product development and maintenance of existing products.

To support the Engineering department in the administrative functions of the department.

Main Duties and Responsibilities

Clinical Compliance

• Following group processes for Clinical Evaluation (CER), ensuring compliance with MDR, FDA requirements and other relevant jurisdictions.
• Creation and maintenance of documentation for technical files: CEP, and CER.
• Maintain the highest ethical, clinical and scientific standards, ensuring the safety and well-being of all trial participants and good/rigorous scientific practice;
• Maintain surveillance of clinical publications of relevance and disseminate appropriately;
• Maintain surveillance of clinical research landscape of ours and competitor products
• Ensure all clinical references on marketing material are appropriate and referenced correctly;
• Additional administrative duties when necessary;
• Maintain compliance with the Company’s quality / business management system at all times.

Management Responsibilities

None

Requirements

Experience and Qualifications Required

Mandatory

• Educated to at least degree level in a relevant discipline and/or demonstrable success in a similar role;
• Experience writing CERs
• Minimum of 2 years’ experience in healthcare / medical device industry

Desirable

• Knowledge of the Neonatal Intensive Care environment;
• Interaction with Clinical Research Organisations;

Key Skills and Competencies

• Working knowledge of international regulatory requirements applicable to clinical evaluation;
• Awareness of research ethics;
• Thorough understanding of the importance of good clinical practice (GCP);
• Clinical interest and ability to interpret clinical information;
• Good interpersonal and communication skills

Other information

As well as being dedicated to providing a great place to work in a rewarding, stimulating and environmentally conscientious environment, we offer an extensive range of benefits, listed below, and actively support learning and development opportunities for all:

• 25 days' holiday pa, rising to 28, plus bank holidays
• Blended working options
• Enhanced pension scheme (with salary sacrifice option)
• Bonus schemes
• Sharesave scheme
• Mind & body wellbeing support
• Healthcare cash plan
• Retailer discounts
• Life assurance
• Enhanced and equal leave & pay for new parents
• Cycle to Work
• SmartTech scheme
• Electric Car Benefit
• Employee referral scheme
• Travel season ticket loan