Hybrid Regulatory Affairs Manager - Global IVD/MedTech

Roche; Indianapolis (IN); Hybrid; USD 106,000 - 197,000; Full time

Benefits offered by this job

Discretionary annual bonus

Benefits package

Job summary

Roche Global Regulatory Affairs seeks a regulatory professional to advance diagnostics access. You will develop regulatory submissions for US FDA IVD instrument/software products and contribute to global plans, collaborating with internal teams and external stakeholders to accelerate approvals.

You will lead adaptation to regulatory changes, influence strategies across regions, and promote independent decision‑making within a diverse, inclusive Roche environment.

Qualifications

• Bachelor’s / Master in Life Science or related field; advanced degree preferred.
• 3-5 years with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in IVDs/Medical devices/Pharma/Biopharmaceutical with significant regulatory affairs experience.
• Knowledge of Daily Management and Continuous Improvement best practices.
• Knowledge of European, US, China and other international regulations; ability to interpret and apply quality standards.

Responsibilities

• Oversee regulatory document and submission compilation, including development of submission/registration dossiers for complex products.
• Interface with external management and stakeholders; build enduring relationships and support audits.
• Lead adaptation to evolving regulatory environments; shape strategies to navigate regulations across regions.
• Partner with stakeholders to address problems/opportunities and influence future product direction at Roche.
• Demonstrate decision-making initiative and contribute to an inclusive, diverse work environment.

Skills

Regulatory affairs

Stakeholder management

USFDA regulations

IVD/Medical devices

Global submissions

Education

Bachelor's/Master in Life Science or related

Job description

Roche Global Regulatory Affairs seeks a regulatory professional to advance diagnostics access. You will develop regulatory submissions for US FDA IVD instrument/software products and contribute to global plans, collaborating with internal teams and external stakeholders to accelerate approvals.

You will lead adaptation to regulatory changes, influence strategies across regions, and promote independent decision‑making within a diverse, inclusive Roche environment.