Technical Reviewer - Active Medical Devices

BSI; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A premier certification body is seeking a home-based Technical Specialist & Scheme Manager to evaluate medical devices for compliance and support manufacturers throughout their certification life cycle. The position requires at least 5 years of experience with active medical devices, a relevant degree, and a deep understanding of regulatory requirements. This role offers a competitive reward package along with flexible working hours and ongoing training in a dynamic international environment.

Servizi

Competitive total reward package

Flexible working hours

Ongoing training and development

Competenze

• A minimum of 5 years of design and development or research and development or testing experience with a variety of active medical devices.
• Bachelor’s degree (or higher) in a discipline relevant to medical device manufacture and use.
• Thorough knowledge of Medical Device regulation, including IEC 60601 Third Edition and ISO 14971.
• Understanding of design control and risk management principles.

Mansioni

• Review and evaluate medical device documentation for compliance.
• Manage certification activities for medical device manufacturers.
• Provide regulatory and operational support to the business.
• Lead and mentor medical devices personnel.

Conoscenze

Design and development experience

Research and development experience

Testing experience

Strong interpersonal communication skills

Ability to prioritize and execute workload

Formazione

Bachelor’s degree in relevant discipline

Strumenti

Regulatory expertise

Descrizione del lavoro

Great that you're thinking about a career with BSI!

Job title: Technical Specialist & Scheme Manager - Active Devices

Location: Home-based position located in the UK or Europe with up to 20% travel for training.

BSI is seeking experienced R&D Engineers to join our Active Medical Devices team as a home-based Technical Specialist & Scheme Manager (Technical Reviewer). If you have hands on experience in the Research, Design or Manufacture of Active Medical Devices we'd love to hear from you.

As a Technical Reviewer, you will work with medical device manufacturers throughout their certification life cycle to place active medical devices on the European market. This position applies a mix of engineering and design knowledge, newfound regulatory expertise, English writing skills, client and project management. You will assess cutting edge technology that will make a difference in patient health and safety and broaden your technical knowledge through ongoing training.

Responsibilities

• Review and evaluate medical device technical and clinical documentation in your areas of competence to assess compliance with MDD 93/42/EEC, MDR 2017/745 and UK MDR 2012 schemes.
• Manage certification activities for a portfolio of medical device manufacturers, including determination of auditing requirements and making recommendations for the issue and maintenance of CE certifications.
• Provide specialist regulatory, operational and strategic support to medical device scheme managers, products specialists and the business in the delivery of CE medical device marking schemes.
• Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.

Qualifications

• A minimum of 5 years of design and development or research and development or testing experience with a variety of active medical devices.
• Bachelor’s degree (or higher) in a discipline relevant to medical device manufacture and use. This may include electronic/electrical, electro-mechanical or biomedical engineering or medical physics.
• Thorough knowledge of Medical Device regulation; at minimum an awareness of the requirements of IEC 60601 Third Edition and the risk management standard ISO 14971.
• Understanding of the principles of design control and risk management.
• Strong interpersonal communication skills.
• Ability of prioritizing and executing individual workload.

Interested? To apply for this role please submit your application today and take the next step in your career as a Technical Reviewer with BSI.

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development and a wide range of flexible benefits that you can tailor to suit your lifestyle.

Do you believe the world deserves excellence?

We are proud to be the business improvement company for other organisations to become more sustainable and resilient and finally to inspire trust in their products, systems, services, and the world we live in.

Headquartered in London, BSI is the world's first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services, including innovative software solutions and cyber security expertise for all industries: from aerospace and automotive to food, construction, energy, healthcare, IT and trade sectors. Incorporated by Royal Charter, we’re truly impartial, and home to the ultimate mark of trust, the Kitemark.

Through our unique combination of consulting, training, assurance and regulatory services we bring solid and broad knowledge to every company.

If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family!

D&I Policy

BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive.

If you require any reasonable accommodations to be made on account of a disability or impairment throughout our recruiting process, please inform your Talent Acquisition Partner.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.