Think Beyond The Label Jobs

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 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

Envista 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.

Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.

Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com .