Sr. Director Regulatory Affairs (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.
In this role, the Sr Director of Regulatory Affairs will report directly into the Vice President of Regulatory Affairs. The Sr Director of Regulatory Affairs will assess and build a strong regulatory team to support the peripheral programs for Medalliance. Key regulatory milestones include obtaining FDA approval for the peripheral product lines. The Sr Director will be responsible for developing and implementing regulatory strategies to align with business goals. The Sr Director will work closely and in collaboration with clinical, research and development, manufacturing, quality, supply chain and other internal functions. The Sr Director will also maintain a high-level of understanding with regard to global regulatory requirements in a changing regulatory environment.
Responsibilities

• Attract, retain and develop top talent for the peripheral regulatory organization
• Ensure adequate staffing is in place and have the appropriate skill set to achieve business objectives
• Ensure team is well-positioned to move from pre-market structure to post-market environment
• Ensure resources are in place to gain and maintain global approvals
• Evaluate current processes and systems and develop world class procedures and compliance practices
• Develop and maintain collaborative relationships with key internal (functional partners) and external (e.g., FDA, EU NB's, PMDA) stakeholders
• Align with all internal and external stakeholders on prioritization to drive organization's goals
• Support internal and external audits (e.g, FDA, Notified Bodies, MDSAP)

Qualifications

• At least 10-15 years of regulatory experience with Class II/III medical devices
• At least 8 years of management experience
• Demonstrated success in obtaining regulatory approvals for pre and post market Class II/III products
• Experience with FDA Presubmission process, IDE submissions, and 510k/PMA
• Required: Bachelor's degree (preferably a science background)
• Plus, but not required: Experience with coronary/peripheral products
• Plus, but not required: Experience with combination products
• Experience managing large diverse team with varying levels of experience
• Skill in prioritizing workflow to meet deadlines
• Capable of working across multiple time zones including Europe
• Ability to develop, empower and drive engagement with staff
• Understands the importance of developing and maintaining strong relationships with external regulatory agencies and other external partners
• Strong organizational development
• Ability to communicate effectively
• Fluent in English

Pay / Compensation
The expected pre-tax pay rate for this position is $190,000 - 271,500 - $353,500
Actual 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