Senior Manager Regulatory Affairs (Systems & Software)

Quick Facts

• Role: Senior Regulatory Affairs Manager (Systems & Software)

• Focus: Pathology instruments, software, and digital technologies

• Work model: Primarily onsite; no remote arrangements

• Locations: Tucson, Branchburg, Indianapolis, or Carlsbad

Description

This role is a strategic regulatory partnership for cross-functional teams, shaping regulatory decisions from early development through global market access and lifecycle management. You will manage complex global submissions for integrated instrument systems and digital technologies, including software, cybersecurity, automation, connectivity, and digital innovation. High visibility and autonomy are central, with opportunities to influence regulatory strategy and solve complex regulatory challenges.

Responsibilities

• Oversee the development of the most complex regulatory submission/product registration dossiers

• Develop and manage global regulatory submission plans; mentor junior team members

• Lead external complex initiatives and collaborations with key stakeholders; maintain and shape health authority relationships

• Adapt organizational regulatory approach to evolving regulatory environments and requirements

• Interpret regulatory thinking and apply strategies across regions with minimal guidance

• Create innovative regulatory strategies to avoid obstacles and accelerate approvals

• Lead complex stakeholder influencing, alignment building, and negotiations to maximize value for Roche and stakeholders

• Make high-impact decisions and drive activities independently across departments

• Drive innovation and problem solving; troubleshoot issues while ensuring compliance

• Lead mitigation strategies to prevent issues before they occur

• Model VAAC leadership behaviors, develop competencies, and drive agility and continuous improvement

• Communicate clearly and confidently, resolving conflict and clearly articulating complex concepts

Requirements

• Bachelor’s or Master’s degree in Life Science, Data Science, or a related subject (advanced degree advantage)

• Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices

• Regulatory experience in IVDs/Medical devices/Pharma/Biopharmaceutical with significant regulatory affairs background (years vary by degree level)

• Ability to manage highly complex work and/or global projects

• Knowledge of European, US, China, and International regulations; ability to interpret and implement quality standards (advantage)

• Preferred: complex regulatory product launch strategies for integrated/modular systems, change control, cybersecurity, and software (SiMDs, SaMDs, AIML) for major global markets

Benefits

• Discretionary annual bonus: may be available based on individual and company performance

• This position qualifies for the benefits detailed in the posting

• Equal opportunity employer; accommodations available for applicants with disabilities