Biological Safety Manager

vor 2 Wochen

Basel, Schweiz Straumann Group Vollzeit

**Role**
- Dynamic role that requires interaction with project teams and manufacturing sites, working to deadlines and managing changing priorities.
- Provide biological safety assessments according to the state of the art and relevant standards including ISO 10993 to support both the development of new products, and the life cycle of existing products.
- Monitor the state of the art to detect and implement necessary changes to biological safety considerations and expectations in relevant processes.
- Provide internal training for the biological safety assessment process.
- Biocompatibility evaluations and tests as required by design & development projects
- Help to train, guide and coach appropriate functions (RA&C, PM, PL) of design & development project teams in Biocompatibility and Risk Management
- Support the integration of PMS feedback to Risk Management
- Support interactions with regulatory authorities including submission preparation, answering questions and inspections.
- Ensuring that products are biologically safe even after sterilisationsterilization
- Development and Improvement of the biological safety process (Documentation, Training, Compliance, Traceability, Statistics).
- Biocompatibility
- Provide, maintain and run the process for assessment of biocompatibility of Straumann products in the development process and through product life-cycle.
- Train all internal stakeholders in requirements of biological safety and processes.
- Maintain external relationships with relevant CROs and manage testing
- Risk Management
- Provide support of the risk management process, particularly in areas concerning biological safety.

**Main Interfaces**
- Design Center
- Manufacturing Sites (including Straumann Group Members)
- External Service Providers
- Identify, set up and maintain working relationships with relevant CROs
- Regulatory Authorities

**Profile**
- Graduate in Biological Sciences or Chemistry (FH/Uni/ETH).
- Masters level advantageous.
- Minimum 5 years professional experience in working in a medical device environment is essential.
- Experience of responsibilities for risk management would be advantageous.
- Fluent (written and spoken) English is essential.
- French and/or German would be advantageous.
- It is essential to be competent in working in diverse multidisciplinary teams across hierarchy levels and between sites in a professional, independent and team oriented manner.
- Must be able to manage work to meet challenging deadlines.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

**Employment Type**:Full Time

**Alternative Locations**:Switzerland : Basel

**Travel Percentage**:0 - 10%

**Requisition ID**:9969

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