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Regulatory Affairs and Clinical Projects Lead
1 month ago
**About the Company**
Intuitive is a leading medical technology company dedicated to transforming the world of minimally invasive care. Our mission is to empower physicians to heal without constraints, and we believe that our innovative solutions can make a meaningful difference in patients' lives.
We are a team of passionate individuals who share a commitment to excellence, innovation, and customer satisfaction. Our values include integrity, teamwork, and respect for diversity, and we strive to create an inclusive and supportive work environment where everyone can thrive.
Job Summary:
The Clinical Project Manager will play a critical role in supporting the launch of our innovative medical devices in Europe. This individual will be responsible for leading the planning, execution, and monitoring of clinical trials, ensuring compliance with regulatory requirements and delivering high-quality results.
Key Responsibilities:
- Develop and execute clinical trial plans, including project timelines, budgets, and resource allocation.
- Lead cross-functional teams to identify and mitigate risks, ensure compliance with regulatory requirements, and optimize trial design.
- Coordinate with investigators, contract research organizations (CROs), and other external partners to ensure smooth trial execution.
- Manage and analyze clinical trial data, identifying trends and insights to inform product development and regulatory submissions.
- Prepare and submit regulatory documents, including clinical trial applications and annual reports.
- Collaborate with commercial teams to develop marketing materials and sales strategies.
- Prioritize and manage competing demands, adapting to changing priorities and deadlines.
Requirements:
- Master's degree in Life Sciences, Medicine, or related field.
- Minimum 3 years of experience in clinical research, with a proven track record in project management.
- Knowledge of medical device regulations and guidelines, including GCP, ISO-14155, and MDR.
- Experience with clinical trial planning, execution, and monitoring, including data analysis and statistical programming.
- Excellent communication, interpersonal, and leadership skills.
- Ability to work effectively in a fast-paced environment, prioritizing tasks and managing multiple projects simultaneously.
- Fluent English language proficiency, with a second European language an advantage.
Salary Range: €90,000 - €120,000 per annum, depending on experience.