About the Role
The Senior Project Manager is responsible for overseeing the development and
management of medical device projects from conception to market launch. This role involves
coordinating cross-functional teams, ensuring compliance with regulatory requirements, and
managing project timelines and budgets.
Key Responsibilities
- Lead and manage technical, cross-functional medical device projects.
- Collaborate with internal and external teams including: R&D, regulatory, quality assurance,
manufacturing and marketing teams to ensure project alignment.
- Develop, track and maintain project plans, timelines, and budgets.
- Identify and mitigate risks associated with project timelines and deliverables.
- Ensure compliance with internal QMS systems, FDA, EU MDR, ISO, and other regulatory
standards.
- Conduct regular project status meetings and communicate updates to external stakeholders .
- Manage relationships with external partners and vendors.
- Prepare and present project documentation and reports.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field; Master’s degree preferred.
Proven experience in project management within the medical device industry.
Strong knowledge of regulatory requirements for medical devices specifically ISO13485 and ISO62304.
Proficiency in project management tools and software.
Certification in project management (e.g., PMP) is a plus.
About the Company
Innovation Zed specialises in the design, research and development of smart connected solutions for drug delivery devices. Through hardware and software solutions as well as manufacturing and services, we streamline the process of turning any injection pen a market ready digital health solution. We are a company with one mission, to create freedom for people requiring injection therapies.