Company Description
Biomedisca is a leading company in the MedTech industry, focusing on developing advanced diagnostic medical devices for preventive healthcare. Our team is dedicated to improving healthcare outcomes through early disease detection and management, offering proactive care solutions. We provide comprehensive support to our clients to maximize the impact of our technology in their practices, setting new standards in the industry.
Job Description
We are seeking a dynamic and results-driven Project Manager to lead and oversee the successful development and commercialization of our medical device projects. The Project Manager will be responsible for managing cross-functional teams, ensuring compliance with regulatory requirements, and coordinating all aspects of the project life cycle from concept through to product launch. This individual will play a critical role in maintaining timelines, budgets, and quality standards, while also serving as the primary point of contact for stakeholders.
Key Responsibilities
- Lead and manage the entire lifecycle of medical device projects, from conception to market launch.
- Develop and execute project plans, including timelines, budgets, resource allocation, and risk management strategies
.
- Ensure all project activities comply with medical device regulatory standards (e.g., FDA, CE, ISO) and quality management systems (e.g., ISO 13485).
- Collaborate with cross-functional teams, including R&D, engineering, regulatory, quality assurance, marketing, and operations, to ensure project alignment and success.
- Track project progress, deliverables, and milestones, providing regular updates to senior leadership and key stakeholders.
- Identify project risks and develop mitigation strategies to ensure timely and cost-effective delivery.
- Manage vendor and supplier relationships as needed, including negotiating contracts and overseeing external partnerships.
- Coordinate and prepare necessary documentation for regulatory submissions, design reviews, and audits.
- Drive continuous improvement initiatives and best practices in project management to optimize processes and outcomes.
Qualifications
- Bachelor’s degree in Engineering, Biomedical Sciences, or a related field (Master’s degree preferred).
- Minimum of 5 years of experience in project management, preferably within the medical device industry.
- Proven track record of successfully leading cross-functional teams and delivering projects on time and within budget.
- Strong understanding of medical device regulations (FDA, CE, ISO) and quality standards (ISO 13485, GMP).
- PMP or similar project management certification is a plus.
- Excellent organizational, communication, and problem-solving skills.
- Proficient in project management tools (e.g., Microsoft Project, Jira, Asana)
Salary: 110,000 - $140,000 per year
In addition to the base salary, many companies offer bonuses, stock options, and comprehensive benefits packages, including health insurance, retirement plans, and performance incentives.