R&D Director
* Oversee the development of innovative products and technologies, ensuring alignment with strategic objectives.
* Lead a high-performing R&D team, fostering collaboration and driving business outcomes.
* Develop and execute plans to achieve clinical and commercial approval, prioritizing stakeholder engagement.
* Establish robust engineering practices and processes in product design and development, ensuring regulatory compliance.
* Align test plans and testing with regulatory requirements, minimizing risk and delays.
* Prepare submission-ready documentation for FDA and other bodies, demonstrating technical expertise.
* Support clinical activities, including limited case support, to drive business growth.
* Investigate product failure modes and root causes, identifying opportunities for improvement.
* Grow the company's IP portfolio through strategic innovation and partnerships.
* Stay up-to-date with technological advancements in the therapeutic domain, applying insights to drive business success.
* Maintain awareness of evolving regulatory standards and their impact on planned work, ensuring adaptability.
* Manage new product development to meet patient, customer, and business needs, driving market differentiation.
* Lead projects, developing plans and goals that align with overall company objectives, promoting collaborative leadership.
* Engage with external vendors and partners as necessary to support product development, fostering strong relationships.
Key Responsibilities:
* Strategic Planning: Develop and execute plans to achieve business objectives, prioritizing stakeholder engagement.
* Team Leadership: Foster a high-performing R&D team, driving collaboration and business outcomes.
* Regulatory Compliance: Establish and maintain robust engineering practices and processes, ensuring regulatory adherence.
* Communication: Prepare submission-ready documentation and communicate effectively with stakeholders.
* Innovation: Grow the company's IP portfolio through strategic innovation and partnerships.
* Adaptability: Maintain awareness of evolving regulatory standards and their impact on planned work.
* Project Management: Lead projects, developing plans and goals that align with overall company objectives.
* Collaboration: Engage with external vendors and partners to support product development, fostering strong relationships.
Requirements:
* 10+ years of experience in R&D management or a related field.
* Proven track record of leading high-performing teams and delivering business results.
* Strong understanding of regulatory requirements and ability to ensure compliance.
* Excellent communication and interpersonal skills, with ability to engage stakeholders effectively.
* Ability to stay up-to-date with technological advancements and apply insights to drive business success.