Regulatory Affairs Manager – CDx Systems & Software
Locations: Tucson (AZ), Indianapolis (IN), Branchburg (NJ), Penzberg (Germany)
Job Type: Full-Time | Permanent
Category: Regulatory Affairs
Sub-Category: General Regulatory Affairs
Industry: Diagnostics / Medical Devices / Companion Diagnostics
Company: Roche
Job Level: Individual Contributor
Experience Required: 5–8+ Years (depending on degree)
Job ID: 202512-131139
Posted Date: 12 March 2025
Job Overview
Roche Global Regulatory Affairs is seeking an experienced Regulatory Affairs Manager – CDx Systems & Software to support global regulatory strategy and market access for innovative Companion Diagnostics (CDx), with a strong focus on systems, instruments, and software-based IVD products.
This role is a key strategic position responsible for driving regulatory submissions, approvals, and compliance across major global markets, primarily the United States and Europe, while collaborating with cross-functional and external stakeholders worldwide.
About Roche
Roche is a global leader in pharmaceuticals and diagnostics, dedicated to advancing science and ensuring access to innovative healthcare solutions. With more than 100,000 employees globally, Roche fosters a culture of integrity, inclusion, collaboration, and innovation to deliver life-changing diagnostics and medicines with global impact.
Key Responsibilities
Regulatory Strategy and Submissions
Lead and manage regulatory documentation, submission compilation, and dossier development for complex IVD and Companion Diagnostic products.
Develop and execute global regulatory submission and registration strategies aligned with business objectives.
Ensure timely regulatory clearance and approvals for CDx systems and software in the US, Europe, and other international markets.
Interpret evolving regulatory requirements and apply regulator expectations to product development and lifecycle management.
Global Regulatory Leadership
Act as a strategic regulatory partner for internal teams, providing guidance across global development programs.
Proactively anticipate regulatory challenges and design innovative regulatory strategies to mitigate risk and accelerate approvals.
Apply regional regulatory strategies tailored to diverse global markets without significant supervision.
Contribute to internal and external audits, including preparation, execution, and follow-up activities.
Stakeholder Engagement and Influence
Build and maintain effective relationships with regulatory authorities, notified bodies, and external stakeholders.
Communicate regulatory requirements clearly and influence decision-making across internal and external partners.
Collaborate closely with cross-functional teams including R&D, Quality, Clinical, Software, and Commercial teams.
Actively participate in stakeholder meetings as a regulatory subject matter expert.
Leadership and Continuous Improvement
Drive adaptation to changing global regulatory environments, leveraging regulatory intelligence and precedents.
Demonstrate strong decision-making skills, including operating beyond defined comfort zones when required.
Model Roche leadership behaviors, including integrity, accountability, agility, and inclusiveness.
Foster collaboration, resolve conflicts constructively, and bring together diverse perspectives to achieve shared goals.
Required Qualifications
Education
Bachelor’s or Master’s degree in Life Sciences, Data Science, Biomedical Engineering, or a related discipline.
Advanced degree (PhD or equivalent) is preferred.
Experience
PhD: 3–5 years of regulatory experience
Master’s Degree: 5–7 years of regulatory experience
Bachelor’s Degree: 6–8 years of regulatory experience
Proven background in IVDs, Medical Devices, Companion Diagnostics, Pharma, or Biopharmaceuticals.
Mandatory experience in Companion Diagnostics (CDx).
Mandatory experience with systems, instruments, or software-based medical devices.
Experience managing complex regulatory projects and contributing to global submissions.
Regulatory Knowledge and Skills
Strong understanding of US (FDA), European (IVDR), and international regulatory frameworks; knowledge of China and other regions is an advantage.
Demonstrated ability to interpret and apply quality and regulatory standards effectively.
Experience with continuous improvement, daily management practices, and regulatory process optimization.
Excellent communication, stakeholder management, and influencing skills in a matrix organization.
Location and Compensation
Candidates must be local to Tucson, Indianapolis, Branchburg, or Penzberg.
No relocation assistance is available for this position.
The expected salary range for Tucson, AZ is USD 103,900 – 193,000, depending on experience, qualifications, and location.
Eligibility for discretionary annual bonus and comprehensive Roche benefits package.
Why Join Roche
Work at the forefront of Companion Diagnostics and digital health innovation
Influence global regulatory strategy for life-changing diagnostic technologies
Collaborate with world-class experts across regions and disciplines
Be part of an inclusive, purpose-driven organization shaping the future of healthcare
Equal Opportunity Statement
Roche is an Equal Opportunity Employer. Employment decisions are based on merit, qualifications, and competence, without discrimination in accordance with applicable laws. Reasonable accommodations are available for applicants with disabilities during the recruitment process.
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