Biological Product Safety Manager

Description

The Biological Product Safety Manager will be responsible for overseeing and ensuring the biological safety of our products.

This role requires expertise in biological safety standards, regulatory compliance, and effective collaboration with cross-functional teams.

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Job Requirements : Resposibilities :

Resposibilities :

Ensure the biological safety of Nobel Biocare’s porfolio, including compliance with relevant standards and guidelines .

Stay abreast of global regulatory requirements related to biological safety and ensure adherence to applicable standards (e.

g. performing gap analysis).

Ensure the life-cycle biocompatibility of Nobel Biocare products and supports compliance projects.

Conduct comprehensive risk assessments to identify potential biological hazards associated with Nobel Biocare products.

Collaborate with cross-functional teams, including Research and Development, Regulatory Affairs, and Quality Assurance, to integrate biological safety considerations into new product development and life cycle management activities.

Coordinate biocompatibility testing with approved vendors

Oversee the review and evaluation of biological safety aspects during the development and lifecycle of products.

Communicate biological safety requirements and updates to relevant stakeholders.

Provide training and guidance to internal teams on biological safety principles.

Develop and implement strategies for responding to and mitigating biological safety concerns

Qualifications :

Bachelor's, Master's, or Ph.D. in Biological Sciences or related field.

Proven experience in ensuring biological product safety

In-depth knowledge of relevant regulations and guidelines (e.g., ISO 10993).

Strong background in Biotechnology, Toxicology, Biology, Chemistry or related science (Ph.D. or equivalent)

Experience :

5 years of experience in a biological product safety role.

Track record of successful collaboration with cross-functional teams.

Experience in conducting risk assessments for biological safety.

Broad understanding of bone and / or mucosa biology, pharmacology and biochemistry

Broad understanding of ISO 13485 and ISO 14971

Skills :

Strong communication skills.

Strong Technical writing skills

Attention to detail and analytical thinking.

Knowledge of global regulatory landscape for biological safety.

Fluent in English (spoken and written), German (spoken and written) is an asset.

Project management skills

Operating Company : Nobel Biocare

Nobel Biocare

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