IVD (In Vitro Diagnostic) Medical Device Technical Expert

BSI; Remote; ZAR 300 000 - 400 000; Full time

Job summary

A global standards organization is seeking a Technical Specialist- IVD to join their team focused on cancer and molecular biology. The ideal candidate will have a relevant Bachelor's degree, with over four years of experience in IVD medical devices. This position is home-based with some travel required. Responsibilities include managing CE marking schemes, conducting technical reviews, and supporting the commercial team. Join us to make a positive impact on patient safety and quality management in the medical field.

Benefits

Competitive total reward package

Flexible working hours

Ongoing training and development

Qualifications

• 4+ years of experience in IVD medical devices design and development.
• Understanding of design control and risk management in medical devices.
• Familiarity with medical device regulations and quality management standards.

Responsibilities

• Manage CE marking schemes focused on medical devices.
• Conduct technical reviews and provide expertise to healthcare personnel.
• Collaborate with the commercial team for technical sales support.

Skills

Technical Sales/Networking

Regulatory Knowledge

Analytical Skills

Communication Skills

Education

Bachelor's degree relevant to IVD

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!

Job Title

Technical Specialist- IVD (In Vitro Diagnostic)

Location

South Korea

BSI is seeking R&D Scientists and Production Scientists to join our IVD Devices Team as a Technical Specialist and Scheme Manager for CE Marking clients. Specifically we are seeking people with knowledge of the design and manufacture of IVD cancer and molecular biology.

Our Technical Specialists are industry experts that are analytical, communicative, diligent, and always curious. If you are looking for a career change and want to make an impact on patient safety – this may be a great fit for you! This is a home-based position with some travel. If interested in this position, please submit your CV in English.

Essential Responsibilities

• Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise
• Deliver technical reviews, scheme management in support of the CE marking schemes
• Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of competence to Healthcare personnel
• Provide “Technical Sales/Networking” support to the commercial team

The Ideal Candidate Will Possess the Following Characteristics

• Bachelor's degree or higher in a discipline relevant to IVD medical device design, manufacture and use, or equivalent qualification.
• At least (4) years' post-graduate experience in the design and development of IVD medical devices, including the principles of design control, risk management and performance and/or clinical evaluation primarily focusing on IVD only cancer and molecular biology.
• Knowledge of medical device regulations.
• Awareness of certification business processes, the application of quality management standards, and audits

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours , ongoing training and development.

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 out our recruiting process, please inform your Talent Acquisition Partner.

About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.

Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.

Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.

Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.