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 that 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
1. Work with the business to develop and document procedures ensuring consistent, compliant service delivery.
2. Support the Compliance & Risk interface with regulatory bodies, manage external audits, and address non-conformities.
3. Conduct internal audits for compliance and improvement according to standards.
4. Maintain CAPA, Concessions, Impartiality, Appeals, Complaints, and other RS compliance processes.
5. Advise the business on developing new and revised services and products.
6. Provide guidance on risk, legal, technical, regulatory, and procedural issues.
7. Deliver training to the Regulatory Services team 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 principles.
3. Knowledge of quality systems, internal auditing, and standards.
4. Familiarity with accreditation/d designation, notified bodies, and relevant standards.
5. Experience with Medical Devices or AI Industry QMS assessment techniques.
6. ISO 13485 auditor qualification preferred; capability to gain it is acceptable. ISO 27001 / 42001 qualification preferred.
Benefits
Enjoy an extensive, competitive rewards package, including annual leave, holidays, learning opportunities, and flexible benefits tailored to your lifestyle.
About BSI
Headquartered in London, BSI is the world's first national standards organization, with over 100 years of experience. We serve over 86,000 companies across 193 countries, offering development, auditing, certification, and training services, including cybersecurity solutions.
Join Us
If you are passionate about making a difference, bring an open and enthusiastic mindset, and apply now to become part of the BSI family
Additional Information
We are committed to diversity and inclusion. If you need accommodations during the recruitment process, please inform your Talent Acquisition Partner.
Our core Behaviours: Client-centric, Agile, Collaborative.
Interviews may be conducted face-to-face or virtually; please communicate your preference.
Note: If you are not a passport holder of the country where the role is based, you may need a work permit. More info available on our Blog.
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