Subchapter Lead, Near Patient Care

Roche; Santa Clara (CA); Hybrid; USD 106,000 - 246,000; Full time

Job summary

An established industry player is seeking a Subchapter Lead for Near Patient Care, focusing on enhancing regulatory affairs capabilities. This pivotal role involves coaching a dedicated team, improving processes, and acting as a subject matter expert with global regulatory bodies. The ideal candidate will possess extensive experience in diagnostics and a strong understanding of IVD and medical device regulations. Join a forward-thinking organization committed to innovation in healthcare, where your leadership will drive significant advancements in patient care.

Qualifications

• 7+ years of experience in Regulatory Affairs within diagnostics.
• Expertise in Near Patient Care devices, especially Continuous Glucose Monitoring.

Responsibilities

• Develop and coach 10-15 Regulatory Affairs staff.
• Maintain and improve processes, data, and technology related to the Subchapter.

Skills

Regulatory Affairs

Stakeholder Management

Leadership

Technical Regulatory Knowledge

Communication Skills

Education

Bachelor's or advanced degree in science

Job description

Join to apply for the Subchapter Lead, Near Patient Care role at Roche.

The Position

As a Near Patient Care Subchapter lead in the Medical Value Assays Chapter, you will be a key member of the Medical Value Assays Regulatory Affairs Leadership Team (MVA RALT). You will be responsible for developing and coaching 10-15 Regulatory Affairs staff, enhancing their technical regulatory knowledge, strategic thinking, and communication skills. Your role includes maintaining and improving processes, data, and technology related to the Subchapter, and acting as a subject matter expert with regulatory bodies worldwide.

Who You Are

• Bachelor or advanced degree in science or a related field.
• 7+ years of experience in Regulatory Affairs within diagnostics or a related industry, with expertise in Near Patient Care devices (preferably with Continuous Glucose Monitoring).
• Knowledge of IVD, Pharmaceutical, and Medical Device regulations, including global submissions (US FDA, EU Notified Bodies, China, etc.).
• Proven leadership in building capabilities and stakeholder management.

Leadership Skills

• Ability to lead creatively with high self-awareness, coaching, and mentoring skills.
• Experience in building high-performing teams and defining career pathways.
• Strong network-building and agile working capabilities.

Locations & Additional Details

Based in Indianapolis, Tucson, Pleasanton, Santa Clara, Branchburg, or Washington DC, with remote work considered. International travel may be required. Salary range: $106,760 - $245,700, plus benefits and potential bonuses.

About Roche

Roche is committed to innovation in healthcare, employing over 100,000 worldwide, dedicated to advancing science and ensuring access to healthcare. We are an equal opportunity employer, promoting diversity and inclusion.