[Hiring] Technical Specialist- IVD @BSI

Role Description

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

BSI is seeking R&D Scientists and Product 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 Molecular oncology and CDx.

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.

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.

Qualifications

• 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 Molecular oncology and CDx.
• Knowledge of medical device regulations.
• Awareness of certification business processes, the application of quality management standards, and audits.

Benefits

• Competitive total reward package.
• Independent and varied job in an international environment.
• Flexible working hours.
• Ongoing training and development.
• 20-days annual leave.
• Bank holidays.
• Medical, dental, vision, and life insurance.
• 401(K) with company contribution.
• Short-term and long-term disability.
• Maternal leave.
• Paid parental leave.
• Paid bereavement leave.
• Learning and development opportunities.
• A wide range of flexible benefits that you can tailor to suit your lifestyle.

Company Description

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.