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Global Development Lead, Molecular Diagnostics Specialist
hace 2 meses
**About Us**
At Empresa Reconocida, we are a leading company in the molecular diagnostics industry, dedicated to making a real difference in science and healthcare. Our mission is to advance our business through innovative solutions and exceptional talent.
**Job Summary**
We are seeking a highly skilled Global Development Lead, Molecular Diagnostics to join our team. This is an exciting opportunity to lead the development of our molecular diagnostic systems, working closely with stakeholders, project teams, and external partners.
**Key Responsibilities:**
- Provide leadership and guidance to R&D teams across multiple projects to ensure technical project delivery.
- Responsible for technical decisions within the assigned projects; technical delivery of project development objectives; communicating technical status of projects; contributing to budget management; compliance with quality and regulatory standards.
- Review product development documentation and supporting data, identify gaps and lead projects to mitigate and/or close these gaps.
- Represent product development in a customer-facing role to provide technical expertise and relationship management with internal and external collaborators and international partners.
- Work in partnership with Regulatory and Quality Affairs teams providing technical input in interactions with notified bodies such as FDA; ownership of the design history file; and guaranteeing high-quality scientific delivery and compliance with industry standards (e.g. CLSI guidelines, ISO standards, 21 CFR part 820, IVDR).
- Coach and mentor staff to ensure continuous development, sharing knowledge and best practices in order to build and nurture a connected and effective team.
**Requirements:**
- Proven experience in leading development teams and projects in the molecular diagnostics industry.
- Strong technical expertise in molecular diagnostics and regulatory affairs.
- Excellent communication and leadership skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
