About the Opportunity:
We are seeking an experienced professional to lead our medical device development and research initiatives.
Key Responsibilities:
* Serve as the primary liaison for external partners, including device manufacturers and delivery suppliers.
* Develop new relationships with pre-clinical testing facilities and Contract Research Organizations (CROs), managing supplier agreements and ensuring quality standards.
* Manage the company's Intellectual Property (IP) portfolio with external patent lawyers, manage specific research projects, and ensure 'freedom to operate.'
* Conduct IP searches and assist with patent applications, ensuring the company's IP strategy and portfolio is kept on schedule.
* Experience with Computer-Aided Design (CAD) software an advantage.
* Lead the planning and implementation of technical projects, collaborate with external partners, monitor project progress, and manage cross-functional project teams.
* Prepare and provide technical consultation for clinical and regulatory documents, draft responses to regulatory agencies, and ensure adherence to international regulations.
* Provide regular, detailed reports to senior leadership on project status, progress against milestones, budget adherence, and risk mitigation efforts.
* Generate investor reports and communicate effectively.
* Manage 3rd party pre-clinical testing facilities and select, negotiate, and manage relationships with CROs.
Requirements:
* Bachelors or Masters degree in sciences, or a related technical discipline.
* Minimum of 2-3 years of project management experience ideally in the medical device industry.
* Experience with device verification, device validation, and regulatory submissions is a distinct advantage.
* Strong understanding of relevant regulatory requirements (FDA, European submissions).
* Experience in the biomedical field, ideally within a smaller company.
* Experience of managing 3rd party pre-clinical testing facilities and selecting, negotiating, and managing relationships with CROs.
* Exceptional written and verbal communication skills, a proficiency in CAD software, and an understanding of marketing and reimbursement strategies would be ideal.
* A Project Management Professional (PMP) or other recognised certification is a significant advantage.
What We Offer:
* Competitive Salary: Attractive compensation package.
* Dynamic Work Environment: Be part of a collaborative and innovative team making a global impact.