Regulatory Affairs Manager
Company: Disability Solutions
Location: Santa Clara
Posted on: November 1, 2024
Job Description:
Roche fosters diversity, equity and inclusion, representing the
communities we serve. When dealing with healthcare on a global
scale, diversity is an essential ingredient to success. We believe
that inclusion is key to understanding people's varied healthcare
needs. Together, we embrace individuality and share a passion for
exceptional care. Join Roche, where every voice matters.The
Position A healthier future. It's what drives us to innovate. To
continuously advance science and ensure everyone has access to the
healthcare they need today and for generations to come. Creating a
world where we all have more time with the people we love. That's
what makes us Roche. At Roche Global Regulatory Affairs we strive
to be the world's best Regulatory organization, championing patient
access to the world's best diagnostics. Our team is tasked with
regulatory projects as well as overarching regulatory topics with
specific focus in systems and software. This role will specifically
support our Digital Pathology portfolio in our Pathology Lab
Customer Area. You can expect an open-minded work environment,
where you will be working closely with colleagues in other
departments and other counties. The Opportunity
- You oversee regulatory document and submission compilation,
which includes the development of submission/product registration
dossiers of more complex products/programs. You develop and manage
parts of comprehensive global regulatory submissions and
registration plans.
- You interface with external management. You understand the
structure, key roles and responsibilities of external
customers/stakeholders and communicate timely and effectively the
needs of external customers/stakeholders. You build effective and
enduring external relationships and apply effective stakeholder
management practices. You contribute to audits by supporting
preparation, execution and follow up.
- You lead the organization to adapt to the evolving regulatory
environment and requirements. You have an understanding of external
environmental changes, precedents, to navigate complex situations
and influence strategies and decision making. You have the ability
to interpret and apply understanding of the regulators' thinking to
projects and apply strategies to the different needs of different
regions without significant guidance. You proactively create
unique/innovative regulatory strategies and influencing approaches
to avoid regulatory obstacles and accelerate world wide
approvals.
- You effectively partner with stakeholders to understand and
provide best solutions. You take initiative to address problems or
opportunities and involve collaborators for best solutions. You
develop relationships that significantly influence the current and
future direction for Roche and our products.
- You have courage to make decisions even outside of
scope/comfort zone and proactively initiate activities
independently. You embrace good decision making principles.
- You model VAAC Leadership and agility. You identify
opportunities to develop VACC competency. You act with integrity,
courage, passion and honor commitments and contribute to an
inclusive environment which supports all dimensions of
diversity.
- You are able to pull people together around a common goal and
seek to understand and build on different perspectives to enhance
outcomes. You address and resolve conflict by creating an
atmosphere of openness and trust. You bring out the best in people
and teams.Who you are
- You have a Bachelor's / Master degree in Life Science, Data
Science or related subject or equivalent experience. Advanced
degree preferred.
- You have 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.
- You have demonstrated experience and knowledge of Daily
Management and Continuous Improvement best practices.
- You have knowledge of the European, US, China and other
international regulations and demonstrated ability to adequately
interpret and implement quality standards considered an
advantage.
- You have demonstrated the ability to manage more complex work
and/or at parts of global projects.LocationsYou are local to Santa
Clara, Branchburg, Indianapolis, Pleasanton or Tucson. You must be
local to a US Diagnostics site. *Relocation assistance is not
available for this position.*The expected salary range for this
position based on the primary location of Santa Clara is
$118,000-$219,000. Actual pay will be determined based on
experience, qualifications, geographic location, and other
job-related factors permitted by law. A discretionary annual bonus
may be available based on individual and Company performance. This
position also qualifies for the benefits detailed at the link
provided below.Who we areAt Roche, more than 100,000 people across
100 countries are pushing back the frontiers of healthcare. Working
together, we've become one of the world's leading research-focused
healthcare groups. Our success is built on innovation, curiosity
and diversity.Ventana Medical Systems, Inc. (Ventana), a member of
the Roche Group, innovates and manufactures instruments and
reagents that automate tissue processing and slide staining for
cancer diagnostics. Our integrated staining, workflow management
and digital pathology solutions optimize laboratory efficiency to
reduce errors and support diagnosis for pathology professionals.
Together with Roche, Ventana is driving personalized healthcare
through accelerated drug discovery and companion diagnostics. Roche
is an equal opportunity employer and strictly prohibits unlawful
discrimination based upon an individual's race, color, religion,
gender, sexual orientation, gender identity/expression, national
origin/ancestry, age, mental/physical disability, medical
condition, marital status, veteran status, or any other
characteristic protected by law.If you have a disability and need
an accommodation in relation to the online application process,
please contact us by completing this form .
Keywords: Disability Solutions, Berkeley , Regulatory Affairs Manager, Executive , Santa Clara, California
Didn't find what you're looking for? Search again!
Loading more jobs...