Project Lead

Project Lead Join a startup Medical Device company and play a pivotal role inprototype development and researchfor new medical devices.

Our client is seeking a professional who can not only assist in bringing new products to life but also help drive advancements in R&D and regulatorysubmissions to FDA and European notified bodies.

If you're passionate aboutmedical device innovation, we want to hear from you.

Important Information before you read on Candidates can be based remotely but there willbe weeklytravel to Galway, Sligo and occasionally Dublin.

Please note that we are unable to provide visa sponsorship for this position.

Candidates must already have the legal right to work in the Republic of Ireland to be considered.

Duties External Partnerships and Supplier Management : Act as the primary liaison for external partners, including device and delivery manufacturers.

Develop new relationships withpre-clinicaltesting facilities and CROs, managing supplier agreements and ensuring quality standards.

Intellectual Property Management : Manage the company's 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 CAD software an advantage.

Project Management and Execution : Lead the planning and implementation of technical projects, collaborate with external partners, monitor project progress, and manage cross-functional project teams.

Regulatory Compliance and Documentation : Prepare and provide technical consultation for clinical and regulatory documents, draft responses to regulatory agencies, and ensure adherence tointernationalregulations.

Reporting and Communication : Provide regular, detailed reports to the CMO and senior leadership on project status, progress against milestones, budget adherence, and risk mitigation efforts.

Generate investor reports and communicate effectively.

Supplier and Facility Management : Manage 3rd partypre-clinicaltesting facilities and select, negotiate, and manage relationships with CROs.

Skills Required Technical Expertise : 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.

Regulatory Knowledge : Strong understanding of relevant regulatory requirements (FDA, European submissions).

Experience : Experience in the biomedical field, ideally within a smaller company.

Experience of managing 3rd partypre-clinicaltesting facilities and selecting, negotiating, and managing relationships with CROs.

Additional Skills : Exceptional written and verbal communication skills,a proficiency in computer-assisted design 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.

Whats on Offer Competitive Salary : Attractive compensation package.

Dynamic Work Environment : Be part of a collaborative and innovative team making a global impact.

Whats Next Apply now toor call for more details.

Skills : Project Management Benefits : Mobile phone Negotiable Laptop Expenses Mileage