GQA Technical and Regulatory Reviewer

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

Technical and Regulatory Reviewer

Location: Homebased- China

This career is about providing medical device QMS ownership to medical device and QMS audit teams globally. This will be achieved through developing and maintaining technical expertise in key areas relating to certificate decision making and technical support of the ISO 13485 certification based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes, such as MDSAP and CE.

In a typical day you'll:

• Support the roll out of policy decisions and processes for medical device QMS audits globally;

• Provide support of the ISO 13485 certification and CE schemes, for example investigating customer appeals, report reviewing and supporting activities during regulator audits;

• Deliver certification decisions for ISO 13485 certifications as eligible, with a goal to being qualified across all non-CE ISO13485 schemes, where resource allows;

• Support in hosting regulator or accrediting body audits and provide advice and support to QMS auditors globally, technical specialists, scheme managers, sales, marketing and other BSI colleagues on BSI QMS requirements for medical devices;

• Competence verifier activities to support the auditor qualification process

To succeed in this career you must:

• Demonstrate your understanding of QMS requirements as applied to medical devices including applicable regulations and standards (ISO 13485 and MDD, AIMD and/or IVDD, MDR/IVDR and MDSAP requirements in particular)

• Have experience of co-ordinating or conducting audits of medical device manufacturers to ISO13485 (e.g. supplier or internal audits)

• Be able to confidently share your understanding of product and QMS certification concepts and principles

• Obtained your degree in engineering, science, or a related discipline

Do you believe the world deserves excellence?

BSI Medical Devices Notified Body provides rigorous CE and ISO 13485 certification to manufacturers globally. The team apply their knowledge to 3rd party conformity assessment of all types of medical devices; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others.

The team has doubled in size over the past eight years, demonstrating the company’s desire to succeed and deliver world beating results. There are exciting opportunities for further growth of the Medical Devices team.

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.