Job Description:
We are seeking an exceptional Project Lead to play a pivotal role in the development and research of new medical devices. As part of our team, you will be responsible for driving advancements in R&D and regulatory submissions.
* You will act as the primary liaison for external partners, including device and delivery manufacturers.
* You will develop new relationships with pre-clinical testing facilities and CROs, managing supplier agreements and ensuring quality standards.
* You will manage the company's IP portfolio with external patent lawyers, lead specific research projects, and ensure 'freedom to operate.'
* You will conduct IP searches and assist with patent applications, ensuring the company's IP strategy and portfolio is kept on schedule.
* You will lead the planning and implementation of technical projects, collaborate with external partners, monitor project progress, and manage cross-functional project teams.
* You will prepare and provide technical consultation for clinical and regulatory documents, draft responses to regulatory agencies, and ensure adherence to international regulations.
Required Skills and Qualifications:
* Bachelor's or Master's degree in sciences or a related technical discipline.
* Minimum 2-3 years of project management experience, preferably in the medical device industry.
* Strong understanding of relevant regulatory requirements.
* Experience in the biomedical field, ideally within a smaller company.
* Exceptional written and verbal communication skills, proficiency in computer-assisted design software, and an understanding of marketing and reimbursement strategies.