Compliance & Risk Manager - Medical Devices, Spain
Location: Spain, Spain (Homebased)
Job Category: Other
EU work permit required: Yes (Check expiry date: 01.06.2025)
About the role
As a Compliance & Risk Manager, you will ensure BSI achieves compliance with accreditation and 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
* Develop and document procedures to ensure consistent, standards- and regulation-compliant service delivery.
* Support compliance interface with regulatory bodies, manage external audits, and address non-conformities.
* Conduct internal audits for compliance and continuous improvement.
* 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, quality systems, and internal auditing principles.
* Knowledge of accreditation, notified body, product, and quality system standards and requirements.
* Experience with Medical Devices manufacturers' or AI Industry QMS assessment techniques.
* ISO 13485 auditor qualification or ability to obtain it; ISO 27001 / 42001 auditor qualification preferred.
Benefits
Enjoy an extensive, competitive rewards package, including annual leave, holidays, development opportunities, and flexible benefits tailored to your lifestyle.
Our Mission
We aim to be the business improvement partner that helps organizations become more sustainable and resilient, inspiring trust in their products, systems, and services. Headquartered in London, BSI has over 100 years of experience and operates globally, serving over 86,000 companies in more than 193 countries with development, auditing, certification, and training services.
Join Us
If you are motivated to contribute to this inspiring mission, bring your enthusiasm to our dynamic team. Apply now and become part of the BSI family
Diversity & Inclusion
We are committed to reflecting the diversity of our communities and creating an inclusive environment where everyone can grow and succeed. If you require accommodations during the recruitment process, please inform our Talent Acquisition Partner.
Our core behaviors: Client-centric, Agile, Collaborative.
Note: We conduct face-to-face interviews when appropriate. If preferred, virtual interviews are available.
Ensure you have the necessary work permit for this position. For more details, visit our Blog.
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