Careers

At Medovate we are always keen to hear from professionals who are at the top of their game.

Passionate about developing medtech innovations from concept, through clinical trials, to market launch and successful adoption? not afraid to try something new?

Latest roles listed below.


Job Title: Regulatory (RA) Affairs Manager

Brief Description

The RA Manager is responsible for managing the Quality Management System (QMS) and other quality and regulatory obligations of the organisation and its products in accordance with international standards, best practice and customer requirements.

Responsibilities

  • Achieve and maintain certification/compliance such as ISO 13485, ISO 14001, FDA QSR etc.
  • Lead Continuous Improvement of company management systems.
  • Input to regulatory aspects of technology & product opportunity evaluation.
  • Lead quality and regulatory aspects within the product development process e.g. requirements capture, standards identification and interpretation, planning and conduct of clinical evaluation and investigations.
  • Work closely with internal and external multi-disciplinary product development teams to ensure project success.
  • Plan and conduct internal audits.
  • Supplier performance evaluation and auditing.
  • Promote audit readiness and lead facilitation of audits of Medovate and partner facilities by external regulatory authorities.
  • Lead engagement with global regulatory authorities regarding the QMS and product certification.
  • Contribute to development and achievement of Quality Objectives and Key Performance Indicators, reporting to the senior management team.
  • Compile and maintain product documentation for initial and ongoing certification.

Knowledge & Experience

  • Minimum 5 years working in the Medical Device industry.
  • Managing an ISO 13485 Quality Management System under the Medical Devices Directive (MDD)/Medical Devices Regulation (MDR) for product development and/or manufacturing in the UK/EU is essential.
  • Knowledge of US FDA 21 CFR 820 Quality Systems Regulation is essential and experience is highly desirable.
  • Knowledge and experience of the medical device EU CE marking process and MDD/MDR is essential.
  • Knowledge of the US FDA product approval process e.g. 510k is essential and experience is highly desirable.
  • Knowledge of other regional quality & regulatory obligations is desirable.
  • Experience of Class I and II devices is essential, Class III is desirable.
  • Experience of sterile single-use devices including process validation is highly desirable.
  • Experience of a wide variety of device technologies and clinical specialties is desirable.
  • Working with external contract design and manufacturing organisations is essential.

Education

  • A degree or higher degree in an Engineering, Science or Regulatory discipline.
  • Member of a professional body would be advantageous e.g. RAPS, TOPRA.

Please click here to download a PDF of the full Job Description.

How to Apply - If you believe you have what it takes to excel in this role, tell us why in a covering letter and send it along with your CV and any supporting information to enquiries@medovate.co.uk

Closing date : Friday 9th August 2019

No agencies please.



Job Title: Project Manager

Brief Description

Owing to significant growth of the Medovate organisation and product development portfolio we have a new opportunity for a Project Manager. We are looking for someone with a solid technical background plus project management experience who wants to further their career in medical device product development. The successful candidate will lead new product development projects with a multidisciplinary team for launch into global markets.

Responsibilities

You will be responsible for leading the successful delivery of product development projects to targets including scope, cost, schedule and quality. This involves both internal stakeholder management, including reporting within Medovate, in addition to close collaboration with external parties such as NHS clinicians, academics, CROs, CDMOs, CMOs and suppliers.

Candidate Requirements

Proven track record of leading and managing full-lifecycle medical device product development projects e.g. from concept, through design and development, clinical trial, regulatory approval, stable manufacture and market launch.

Knowledge of the quality and regulatory framework within which medical device product development and manufacture is performed.

A keen interest in healthcare, technology and project management and a desire to grow.

A team player with excellent organisational and communication skills.

A higher degree in engineering or other relevant life-science field is essential (or equivalent experience)

A minimum of 5 years’ experience in medical device development, including a minimum of 2 years’ project management experience.

Please click here to download a PDF of the full Job Description.

How to Apply If you believe you have what it takes to excel in this role, tell us why in a covering letter and send it along with your CV and any supporting information to enquiries@medovate.co.uk

Closing date : Friday 26th July 2019

No agencies please.



Job Title: Clinical Associate - NHS Secondment Opportunity

Brief Description
Owing to significant growth of the Medovate organisation and product development portfolio we have a new opportunity for a Clinical Associate secondment on a 0.5 FTE basis . We are looking for a qualified clinician currently working in the NHS with experience developing medical technologies and influencing their uptake in the NHS. The successful candidate will lead clinical evaluation for company portfolio technologies.

Responsibilities
You will be responsible for clinical engagement activities on Medovate technologies which will include conducting clinical literature reviews and to create clinical evaluation reports in line with Medovate’s Quality Management System (QMS) and CE regulatory approval activities. The post will involve creating and designing clinical study protocols and clinical evaluations for Medovate technologies and supporting the actual clinical studies for these projects. In addition the post holder will contribute and lead the generation of clinical publications related to Medovate technologies supported by Medovate’s NHS partners and establish clinical key opinion leader groups to contribute to the evaluation, design, development of projects in line with the Company’s QMS.

Candidate Requirements
A keen interest in improving healthcare, using innovation and technology as the main drivers

Be able to demonstrate a knowledge of medical technologies, their regulatory environment and the importance of clinical engagement relating to the development of innovative new medical technologies within the life sciences sector

A qualified clinician working within the NHS with experience developing medical technologies and influencing their uptake in the NHS is desirable

Experience of assisting health related innovations and IP through to commercialisation is desirable, but not essential

A skilled report writer with attention to detail, highly motivated to consistently deliver quality outputs

An aptitude to quickly acquire knowledge to gain the confidence of the varied client base and clinicians we work with

Knowledge and understanding of the NHS, including organisational structures, procurement mechanisms, and an understanding of general healthcare delivery pathways is desirable

Strong interpersonal, verbal and written communication skills

A team player that is motivated by the success of the business

Excellent project management and organisation skills

A self-starter committed to making things happen with the ability to motivate others

Excellent IT skills including a good understanding of Microsoft Office software e.g. Word, Excel and PowerPoint

Experience of Key Opinion Leader interviews, human factors research, customer insight and / or clinical stakeholder research

Ability to travel independently to venues around the UK at times and for durations required by the role. This may require the post holder to be away from the main base of operations for overnight periods and may also include international travel.

Please click here to download a PDF of the full Job Description.

How to Apply
If you believe you have what it takes to excel in this role, tell us why in a covering letter and send it along with your CV and any supporting information to enquiries@medovate.co.uk

No agencies please.

Register Interest

Medovate is an innovation development company dedicated to bringing novel medical technologies to market.