Program Director R&D (Medalliance)

Overview

MedAlliance, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).

 

If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then this is the place for you.  Join us, and let's improve the wellbeing of millions, together.

We are the people behind the people who keep saving lives.

 

Location: Irvine, CA or Remote (Based on Qualifications)

 

Cordis is a pioneering medical technology company specializing in groundbreaking solutions for cardiovascular and peripheral vascular diseases. Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.

 

As a Program Director at Cordis, you will assume a pivotal role in steering the successful execution of SELUTION programs. As the Program Director and Core Team Leader, you will guide cross-functional teams in executing US and global product approvals and launches, driving innovation in the medical technology space.

 

Responsibilities

Strategic Project Management: Provide strategic oversight and guidance to the program analyst, ensuring meticulous maintenance of project Gantt charts, identification of critical paths, and proposing effective solutions to address potential roadblocks.

 

Cross-Functional Team Leadership: Lead cross-functional core team meetings to foster effective communication and collaboration among team members, promoting a cohesive and efficient working environment.

 

Risk Mitigation: Oversee the risk register, proactively identifying and addressing potential issues that may impact project timelines and objectives, ensuring a proactive and strategic approach to risk management.

 

Task Tracking and Milestone Management: Supervise project tasks, ensuring milestones are met, and project objectives are achieved within specified timelines.

 

Budgetary Oversight: Take ownership of the program budget, demonstrating adept management skills to ensure projects are executed within financial constraints.

 

Regulatory Documentation Management: Maintain the design history file, ensuring accuracy, completeness, and compliance with company and regulatory standards for all project documentation.

 

Communication and Reporting: Responsible for maintaining high-level program dashboards, providing regular report-outs to Senior Leadership, and disseminating program updates throughout the organization.

 

Qualifications

Candidate Requirements:

•  

  Educational Background: College degree in engineering or related field.
• Regulatory Mastery: Mastery of FDA-mandated design controls (21 CFR 820).
• Experience: 10+ years of experience in the medical device or related industry, with a proven track record of managing successful programs.

Skills and Qualities:

• Analytical and Problem-Solving Skills: Strong analytical and problem-solving capabilities.
• Organizational Skills: Excellent organizational and time management abilities.
• Communication: Effective communication and interpersonal skills.
• Proactivity: Proactive and detail-oriented approach to program management.
• Collaborative Team Player: Ability to work collaboratively in a cross-functional team.
• Regulatory Knowledge: In-depth knowledge of medical device industry regulations and quality standards.
• Technology Proficiency: Proficiency in project management software and tools.

Benefits:

• Competitive Compensation: Competitive salary and benefits package.
• Professional Growth: Opportunities for professional growth and development.
• Cutting-Edge Technology: Access to cutting-edge medical technology and innovations.
• Dynamic Work Environment: A collaborative and dynamic work environment.

If you are a highly motivated and organized individual with extensive experience in Program Management and a passion for advancing medical technology, we invite you to join the Cordis team as a Program Director. Be a part of our mission to make a meaningful difference in the lives of patients worldwide through the innovative SELUTION program.

Cordis is an equal opportunity employer and welcomes applications from candidates of all backgrounds and experiences. To apply, please submit your resume and cover letter detailing your relevant experience and qualifications.

 

Pay / CompensationThe expected pre-tax pay rate for this position is $185,000 - $264,750 - 344,500Actual pay may fluctuate outside of the range depending on skills, education, experience, job-related knowledge and location.

 

Benefits: Med Alliance offers a competitive benefits package including:  

• 401(k)
• Medical, Dental and Vision Insurance
• Life insurance
• Paid time off

Employment Type: FULL_TIME