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Introduction to Employment Positions and Contracting with Kinesys Consulting Ltd
Kinesys Consulting provides Strategic Development, Regulatory Affairs and Technical Writing support and services to a highly varied portfolio of clients within UK, Europe and USA, as well as in emerging and other markets. Since 2007, we have been known as a high-quality service provider whose senior consultants have a wealth of experience and expertise across most biopharmaceutical product classes, therapeutic areas and regulatory applications. We regularly represent clients at EMA, EU NCAs, and US FDA for different types of projects and Applications, including at key regulatory meetings such as Oral Explanations and Appeals. The company benefits from a top class Advisory Board whose members are available to help resolve our clients’ regulatory, clinical, nonclinical and CMC challenges. Kinesys’ Head Office is based in Glasgow, UK, while some senior consultants are located in other parts of EU and USA. Kinesys provides consultancy and contracting services to many major pharmaceutical companies and to both large and developing Biotechnology firms. We also provide Non-Executive Director and Scientific Advisory Board members. We specialise mainly on filling our client’s more senior roles, for which significant relevant knowledge and experience is required. We do, however, receive requests for more junior positions, especially in regulatory affairs and writing roles.
Medical Devices Consultant
Full-time / Part-time Position
Kinesys was formed in 2007 as a successor to GMG BioBusiness Ltd, a successful Regulatory Affairs and Product Development consultancy set up in 1998 and acquired by a major CRO in 2005. Kinesys provides consultancy in the areas of Drug Regulatory Affairs, Medical Devices and Scientific / Regulatory Writing to clients around the globe. Kinesys’ services cover all types of pharmaceutical products, medical devices and biotechnology agents across most therapeutic areas.
Recent growth in our organisation has resulted in the need for a new consultant with specialism in the medical device sector. This post requires the successful candidate to have a practical working knowledge of medical device development, as well as the regulatory framework relevant to product development and quality management in the medical device sector. The role involves client facing work to support their quality and regulatory requirements.
Reporting to the Director of Medical Device, Quality and Regulatory Affairs, this post is ideally suited to candidates with a minimum of 7 years in quality or regulatory affairs roles, and recent management or consultancy experience in the medical device sector, and who are now ready to expand their knowledge and exposure to a wider range of product types and services. This is a new and exciting opportunity for a medical device specialist to become an active and vital member of staff within our growing company and expanding medical device team.
The successful candidate must have / be:
- A degree or equivalent in a scientific or engineering discipline.
- 7+ years’ work experience in medical device quality or regulatory affairs.
- Knowledge and understanding of the regulatory framework for approval of medical devices in the UK and EU. Knowledge of the US devices environment would be an advantage.
- Experience implementing and maintaining an ISO 13485 compliant QMS.
- Adaptable and able to apply analytical skills in diverse situations.
- Dynamic with a strong customer focus, exceptional communication and computing skills, and be a strong team player.
- Experience with auditing.
- Experience in generating Product Conformity Documentation.
- Able to live and work in the UK and have a full driving licence.
Desirable experience includes:
- Knowledge of software as a medical device.
- Experience with IVDs and companion diagnostics.
The post can involve travel to locations throughout the UK and abroad. Kinesys is taking a flexible approach to this position and will consider part-time and full-time options. Hybrid or home working may be available for the right candidate, at discretion of management.
Compensation package
Competitive salary, plus bonus and pension, commensurate with candidate experience and skill set. Continuous professional development.
Please send a full CV to info@kinesysconsulting.com.
Spontaneous Application
Are you looking for a consultant or contractor position? If so, please follow the instructions below:
- Please send a full CV to info@kinesysconsulting.com.
- Please include a cover letter setting out a short description of your profile and experience, the type of position that you are seeking (role, contract duration, geographical preference, expected salary / fee) and any other relevant information.
- Kinesys will then contact you to conduct a short interview and to discuss further your objectives and potential roles.