Product Expert

**General information**:

- Location
- El Prat de Llobregat
- Type of contract
- Permanent
Full Time
- Occupational field
- Medicine & Healthcare
- Job-ID
- 11851

**Job Summary**:
Evaluates complex medical devices with medium risk and the according documentation.
- Evaluates complex medical products according to the relevant technical regulations and relevant EC directives, including documentation that conforms to standards.
- Reviews the technical documentation / design dossiers of medical devices with medium risk.
- Conducts Evaluations in several special areas depending on the product group and degree of authorization:

- Sterilization and its validation
- Preparation of medical products
- Packaging and its validation
- Clean room qualification and monitoring
- Product and personal hygiene
- Evaluation of biotechnology-based production processes, software
- Radiation
- Conducts evaluation of fundamental aspects that play a role in the context of product-related evaluations.
- Creates a compliant documentation.
- Acts as Certifier and / or specialist certifier if required.
- And other duties as assigned.

LI-ES

**Experience & Further Qualifications**:

- Degree in a technical, scientific or engineering field.
- At least 2 years professional experience in development, production, quality assurance, regulatory affairs or quality management of medical devices (related to IVD area);
- Four years of professional experience is a plus.
- Auditor training is a plus to ISO 13485 or ISO 9001.
- Knowledge of relevant guidelines, norms, and product specific standards;
- Fluent in Spanish and English, Portuguese is a plus.
- Local and international business trips are required (depending on job position focus as Auditor and/or Product Expert 20 to 35% per month).

**We can we offert to you?**:

- Hybrid mode of work 70% office - 30% remote.
- Stable job with permanent contract.
- Employee training and development.
- Negotiable salary package.
- International environment and daily use of foreign languages.
- Flexible compensation package: meal card, transportation card, company health insurance policy and childcare vouchers.

**Location**:
Cl Garrotxa 10-12 Parc de Negocis Mas Blau
08821 El Prat de Llobregat

**Company**:
As an international services group, we want to create a working environment in which all our employees feel secure and comfortable - an environment in which they enjoy giving their best with commitment. The key to this lies in an open, respectful cooperation across all countries, cultures and lifestyles. After all, around 20,000 employees at 500 locations around the globe provide more than 2,500 services. The results of their work can be seen everywhere: in tested elevators or rides, on certified toys or technical equipment, in our consultations or training sessions. No matter where - our international teams have been setting standards in terms of safety, quality and efficiency for many years.

**We value diversity - and take on responsibility**:
Our specialists appreciate this versatile portfolio, the exciting tasks and the value of their work for people, the environment and technology. And we value our specialists for their know-how and commitment, but also for their different personalities and careers. Combined with the professionalism and sense of responsibility of each individual, we create a culture of openness, growth and collegiality. We want to further strengthen this culture and consistently promote respect in our dealings with one another. Not only do we say that, we live that. We have committed ourselves to acting in accordance with the principles of the UN Global Compact initiative, to fighting corruption and to working for human rights, labour standards and environmental protection in our daily work. We are active in numerous networks and projects that stand for diversity and equality. In addition, we have developed a broad range of products and services that help to reconcile the professional and private worlds so that our employees can work in a healthy, motivated and optimal environment.