Regulatory Affairs Manager - IVD Instruments and Software

Roche

1d•$106,100 - $197,000•Hybrid

About The Position

At Roche, we are driven by the goal of a healthier future, advancing science to ensure more people have access to the healthcare they need. We are seeking a colleague to join our Global Regulatory Affairs team, specifically supporting regulatory projects and strategic topics for Laboratory Instruments, consumables, and Software, with a focus on integrated hardware and software instrument systems. This role will concentrate on our Pathology and Digital Pathology portfolio within the Pathology Customer Area. 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.
3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards.
Demonstrated ability to manage more complex work and/or at parts of global projects.
Knowledge of USFDA regulations including IVD Instrument and Software, Accessories and System Reagents.

Nice To Haves

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

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.
Interpret and apply understanding of regulators' thinking to projects and develop strategies for different regional needs without significant guidance.
Proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.
Partner with and influence stakeholders to understand and provide optimal solutions.
Take initiative to address problems or opportunities and involve collaborators for best solutions.
Develop relationships that significantly influence the current and future direction for Roche and its products.
Make decisions independently, even outside of scope/comfort zone, and embrace good decision-making principles.
Model VAAC Leadership and agility, identifying 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, seeking 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.