Regulatory Affairs Manager - IVD Instruments and Software

Roche•Tucson, AZ

12d•Hybrid

About The Position

At Roche, we are driven by a mission to advance science and improve healthcare access for everyone, today and for generations to come. We are seeking a colleague to join our Global Regulatory Affairs team who is passionate about bringing world-leading diagnostics to those who need them. In this role, you will support regulatory projects and strategic initiatives for our Laboratory Instruments, consumables, and Software, with a particular focus on integrated hardware and software instrument systems within our Pathology and Digital Pathology portfolio. You will work in a collaborative environment, partnering with colleagues across functions and countries to shape regulatory pathways and facilitate patient access to innovative diagnostics.

Requirements

Bachelor’s / Master’s degree in Life Science, Data Science, or related subject, or equivalent experience. Advanced degree preferred.
3-5 years of experience with a PhD degree, 5-7 years with a Master's degree, and 6-8 years with a Bachelor's degree in IVDs/Medical devices/Pharma/Biopharmaceutical with significant experience in Regulatory Affairs or equivalent.
Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
Knowledge of USFDA regulations including IVD Instrument and Software, Accessories and System Reagents.
Demonstrated ability to manage more complex work and/or parts of global projects.

Nice To Haves

Knowledge of European, US, China, and other international regulations and demonstrated ability to adequately interpret and implement quality standards is considered an advantage.
Experience with medical laboratory instruments, accessories, consumables, and software product launch strategies for USFDA, EU, and other global geographies.

Responsibilities

Oversee regulatory document and submission compilation, including the development of submission/product registration dossiers for complex products/programs.
Develop and manage parts of comprehensive global regulatory submissions and registration plans.
Interface with external management, understanding their structure, key roles, and responsibilities, and communicating effectively.
Build effective external relationships and apply stakeholder management practices.
Contribute to audits by supporting preparation, execution, and follow-up.
Lead the organization in adapting to the evolving regulatory environment and requirements.
Understand external environmental changes and precedents to navigate complex situations and influence strategies and decision-making.
Interpret and apply understanding of regulators' thinking to projects and apply strategies to meet the needs of different regions without significant guidance.
Proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.
Effectively partner with and influence stakeholders to understand and provide optimal solutions.
Take initiative to address problems or opportunities and involve collaborators for the best solutions.
Develop relationships that significantly influence the current and future direction for Roche and its products.
Make decisions outside of scope/comfort zone and proactively initiate activities independently.
Embrace good decision-making principles.
Model VAAC Leadership and agility.
Identify opportunities to develop VACC competency.
Act with integrity, courage, passion, and honor commitments.
Contribute to an inclusive environment that supports all dimensions of diversity.
Pull people together around a common goal and seek to understand and build on different perspectives to enhance outcomes.
Address and resolve conflict by creating an atmosphere of openness and trust.
Bring out the best in people and teams.