Compliance & Risk Manager - Medical Devices, Spain
Location: Spain
Job Category: Other
EU work permit required: Yes (expiry date: 01.06.2025)
Job Description
Join BSI as a Compliance & Risk Manager to ensure compliance with accreditation and designation requirements for Regulatory Services certification activities. Support quality management system processes including management review, internal audits, complaints, appeals, CAPAs, and document control. Provide compliance support across all RS Certification Schemes and align processes within global Regulatory Services Schemes.
Responsibilities
1. Develop and document procedures to ensure consistent, standards- and regulation-compliant service delivery.
2. Manage external audits and address non-conformities with regulatory bodies.
3. Conduct internal audits for compliance and continuous improvement.
4. Maintain CAPA, concessions, impartiality, appeals, complaints, and other compliance processes.
5. Advise on developing new and revised services and products.
6. Provide guidance on risk, legal, technical, regulatory policies, and procedures.
7. Deliver training to Regulatory Services teams as needed.
8. Support and develop the Regulatory Services Compliance & Risk Team.
9. Stay informed of certification, accreditation, and regulatory requirements.
Qualifications
1. Degree or equivalent with relevant experience.
2. Understanding of product certification, quality systems, and internal auditing principles.
3. Knowledge of accreditation, notified bodies, and quality standards.
4. Experience with Medical Devices or AI Industry QMS assessment techniques.
5. ISO 13485 auditor qualification preferred; capability to gain it is desirable. ISO 27001 / 42001 qualifications are also advantageous.
Enjoy competitive rewards, flexible benefits, and opportunities for professional development at BSI. If you believe in striving for excellence and want to contribute to a global leader, apply now to join our team.
We are committed to diversity and inclusion, providing accommodations for disabilities during the recruitment process. Our behaviors include being client-centric, agile, and collaborative.
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