Medical Device Technical/Regulatory Reviewer(home based)

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Job Title: Technical /Regulatory Reviewer for Regulatory Services Global Quality & Accreditation

Location: Global (home based)

We have an exciting opportunity for a Technical /Regulatory Reviewer to join our Regulatory ServicesGlobal Quality & Accreditation team. The role is to provide medical device quality management system ownership to medical device and QMS audit teams globally. The role comprises of three main elements:

• Developing and maintaining technical expertise in key areas relating to certificate decision making, competence verification and competence monitoring.

• Supporting in ad hoc improvement projects.

• 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.

The position will report to the Global Quality and Accreditation Technical Manager- Medical Devices and is home based. Some travel to BSI and third-party locations around the globe for training delivery, conferences and business meetings is desirable, but is not mandatory.

Responsibilities:

• 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 schemes, where resource allows.

• Competence verifier activities to support the auditor qualification process.

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

• Participating in smaller improvement projects ensuring appropriate adherence to procedures.

• 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.

To be successful in the role, you will have:

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

• Minimum of two years of hands-on manufacturing experience and two years quality management experience.

• First or second degree in engineering, science or related discipline.

• A good 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).

• A good understanding of product and QMS certification concepts and principles.

• A comprehensive understanding of quality systems, philosophies and principles.

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.