Compliance & Risk Manager - Medical Devices, Spain
Location: Spain, Spain
Job Category: Other
EU work permit required: Yes (expiry date: 01.06.2025)
Job Description
Great that you're thinking about a career with BSI
Job Title:
Compliance & Risk Manager - Medical Devices
Location:
Homebased
About the role:
As a Compliance & Risk Manager, you will ensure BSI achieves compliance with accreditation/designation requirements for all Regulatory Services certification activities. You will support the management of BSI's quality management system processes, including management review, internal audits, complaints, appeals, concessions, CAPAs, and document control. Additionally, you will provide support and compliance input across all RS Certification Schemes and help align processes within the global Regulatory Services Schemes.
Responsibilities:
* Work with the business to develop and document procedures ensuring consistent service delivery compliant with standards and regulations.
* Support the Compliance & Risk interface with regulatory bodies, manage external audits, and address non-conformities.
* Conduct internal audits for compliance and improvement according to applicable standards.
* Maintain CAPA, Concessions, Impartiality, Appeals, Complaints, and other RS compliance processes.
* Advise on developing new and revised services and products.
* Provide guidance on risk, legal, technical, regulatory policies, and procedures.
* Deliver training to the Regulatory Services team as needed.
* Support and develop the Regulatory Services Compliance & Risk Team.
* Stay informed of certification, accreditation, and regulatory requirements.
Qualifications:
* Degree or equivalent with relevant experience.
* Understanding of product certification concepts & principles.
* Knowledge of quality systems, internal auditing, and philosophies.
* Understanding of accreditation/designation, notified body, and standards requirements.
* Experience with Medical Devices manufacturers' or AI Industry QMS assessment techniques.
* ISO 13485 auditor qualification or ability to obtain it; ISO 27001 / 42001 qualifications preferred.
Additional Information
BSI offers an extensive, competitive rewards package, including leave, holidays, learning opportunities, and flexible benefits.
Our Mission:
We aim to promote excellence and trust in products, systems, and services worldwide, contributing to sustainability and resilience.
About BSI:
Headquartered in London, BSI is the world's first national standards organization, with over 100 years of experience, serving over 86,000 companies globally in development, auditing, certification, and training services.
Application Info:
If interested, bring your enthusiasm to our team by applying now to join the BSI family
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