Compliance & Risk Manager- Medical Devices

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Job Title : Compliance & Risk Manager- Medical Devices

Location : Homebased

About the role :

As a Compliance & Risk Manager, you will ensure that BSI achieves compliance to accreditation / designation requirements for all Regulatory Services certification activities.

Also, supporting the management of BSI’s quality management system processes for management review, internal audits, complaints, appeals, concessions, CAPAs and document control.

Finally, providing support and compliance input and address queries across all RS Certification Schemes and for the alignment of processes within the global Regulatory Services Schemes.

Responsibilities :

• Working with the business to ensure that procedures are appropriately developed and documented to ensure consistent service delivery compliant with standards and regulations.
• Providing support in the Compliance & Risk interface with the respective regulatory bodies. This includes managing the external audit process and the closure of non-conformities raised during these audits to ensure continued operation as an accredited / designated certification body.
• Carrying out internal audits in the Regulatory Services business stream for compliance and improvement according to the applicable standards.
• Maintaining CAPA, Concessions, Impartiality, Appeals, Complaints, and other RS compliance processes BMS maintenance and procedural compliance of all RS documentation
• Providing advice to the business in the process of developing new and revised services and products taking cognisance of the risks to the business.
• Providing general advice and guidance to Regulatory Services team on risk, legal, technical, regulatory policy and procedural issues.
• Delivering training where required to Regulatory Services stream.
• Any other duties required to support and develop the Regulatory Services Compliance & Risk Team
• Remain informed of certification, accreditation, and regulatory requirements.

To be successful in this role, you will :

• Degree or equivalent and relevant experience
• A good understanding of product certification concepts & principles
• A good understanding of quality systems, philosophies and principles and internal auditing principles and practices
• A good understanding of the application of accreditation / designation, notified body, product and quality systems standards and requirements.
• A good understanding of Medical Devices manufacturers’ or AI Industry QMS assessment techniques.
• ISO 13485 auditor qualification or capability to gain ISO 13485 auditor qualification ISO 27001 / 42001 auditor qualification or capability to gain ISO 27001 / 42001 auditor qualification preferred

As a team member at BSI, you will enjoy an extensive, competitive total rewards package. This includes annual leave, bank holidays, learning and development opportunities, 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 organizations 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.

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Our Excellence Behaviours : Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI.

They help us ensure that BSI is a great place to work and a highly successful business.

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.