Compliance Consultant

As the Compliance Officer, you will be responsible for ensuring that the product for each project, as well as the corporate and patient data, meet all external and internal requirements and standards for compliance in both the EU and the USA. This includes ensuring that the data is fit for its intended purpose, consistent, and compliant with all relevant regulations.

**Position duties and obligations (responsibilities and requirements)**:

- Ensuring that the product, corporate data, and patient data meet all external and internal requirements and standards for compliance in both the EU and the USA
- Supporting internal procedures and training
- Reviewing QMS documentation and ensuring compliance with ISO 13485, ISO 9001, MDR 2017/745, ISO 14155, 21 CFR Part 820, and other relevant regulations
- Collaborating with the rest of the team and participating in team work
- Conducting internal audits
- Communicating and coordinating actions effectively during the assessment process
- Keeping up to date on new standards and regulations in both the EU and the USA
- Maintaining ethical standards and reporting any noncompliances
- Writing and updating detailed guides on data protection policies
- Monitoring the CAPA process
- Overseeing onboarding and offboarding processes in collaboration with HR and Admin
- Reviewing the risk impact of each project

**Reports to**:
Quality Leader

**Necessary Competence (education/qualification)**:

- Background or degree in Industrial Engineering
- Strong understanding of data protection regulations and compliance standards, particularly in the EU and USA
- Excellent attention to detail and ability to identify and address noncompliances
- Strong communication skills, both verbal and written, with the ability to effectively convey information to both technical and non-technical audiences
- Ability to work independently and as part of a team
- Strong problem-solving skills and ability to identify and implement effective solutions
- Ability to manage multiple tasks and prioritize work effectively
- Proficiency in Microsoft Office and other relevant software
- Experience with quality management systems and internal audits is a plus
- Experience in data protection and privacy is a plus

**Salary**: 20,000.00€ - 27,000.00€ per year

**Language**:

- english (required)

Work Location: Hybrid remote in Córdoba