Lead Regulatory Affairs Subchapter — Lab Coagulation

Roche; Pleasanton (CA); On-site; USD 111,000 - 259,000; Full time

Job summary

Roche is seeking a Lab Coagulation and Clinical Chemistry II Subchapter lead within the Medical Value Assays Regulatory Affairs group. You will mentor 10–15 staff, act as the regulatory SME with FDA and international bodies, and drive cross-functional collaboration to advance project objectives.

You will influence regulatory strategies across US and global submissions, manage resources, and promote agile leadership while navigating a dynamic, global organization.

Qualifications

• 7+ years in Regulatory Affairs within diagnostics or related field.
• Experience with global submissions for US FDA (Class 1-3) and EU Notified Bodies (Class A-D).
• Knowledge of cGMP, QSRs, ISO13485 and 2701; regulatory compliance across regions.

Responsibilities

• Develop and coach 10–15 Regulatory Affairs staff to maximize impact.
• Serve as SME with US FDA, Notified Bodies and other regulatory agencies; monitor regulatory enviroments.
• Lead resource management across the team; drive standardization and reuse of assets.
• Promote Agile Leadership and cross-functional collaboration within the organization.

Skills

Regulatory Affairs

FDA interactions

Regulatory strategy

Stakeholder mgmt

Agile leadership

Education

Bachelor or Advanced degree in science or related field

Job description

Roche is seeking a Lab Coagulation and Clinical Chemistry II Subchapter lead within the Medical Value Assays Regulatory Affairs group. You will mentor 10–15 staff, act as the regulatory SME with FDA and international bodies, and drive cross-functional collaboration to advance project objectives.

You will influence regulatory strategies across US and global submissions, manage resources, and promote agile leadership while navigating a dynamic, global organization.