Biological Product Safety Manager
vor 1 Woche
Job 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 :
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 concernsQualifications:
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 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 14971Skills:
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 skillsOperating Company:
Nobel BiocareEnvista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
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