Regulatory Affairs Business Process Manager - REMOTE
Location: San Jose
Posted on: June 9, 2021
Essential job responsibilities:
Interact with departments to generate work instructions,
protocols and report templates to expedite submission process and
reduce the review timelines by the agencies.
Lead regulatory assessments in Agile, support the team in the
review and approval of Change Orders.
Provide regulatory assessments for anticipated analytical,
manufacturing and packaging changes. Lead regulatory activities
including planning and reviewing of regulatory submissions
Track regulatory impact for anticipated changes and support
global communication of changes.
Develop solutions to improve processes for regulatory
submissions. Identify, implement, support validation and oversee
software tools for organizing regulatory files, registration
tracking and documentation for submissions.
Manage, guide, mentor and lead a team of 2 or more team
Review and generate a gap assessment report on new guidance and
standards to provide to management and recommend follow-up
Handle all aspects of the regulatory database as well as
enhancements. Interact with global regulatory leaders and peers to
share and manage department metrics and KPIs.
Provide regulatory training to cross-functional groups.
Support continued improvement to databases including TrackWise,
ERP system, Business Intelligence databases and reports, Regulatory
guidance documents, International standards databases and
- Support and lead the regulatory module of the ERP system to
streamline Regulatory Blocks and orders to meet On-Time Delivery to
Education and Experience (in years):
High school diploma with 8+ years of experience OR
Bachelor's degree with 5+ years of experience OR
Master's degree with 3+ years of experience
- Knowledge and experience with emphasis in regulatory/Quality or
related departments within an IVD or Medical Device industry
Knowledge and skills:
Must have the ability to succeed in a fast-paced and changing
Demonstrate in-depth understanding of advanced
technical/scientific principles that relate to multiple, diverse,
and or complex product lines or manufacturing processes
Ability to interpret subjective and complex aspects of specific
regulations and has thorough understanding of multiple sets of
Highly proficient in Microsoft Word, Excel, Power Point and
- Travel - 20%
Someone with Master's or Bachelors with product change
assessment and global authority notification experience in an IVD
Prior knowledge of different databases like SAP, Sales Force,
Tarius, TrackWise etc. including Agile documentation system is
IVD product experience is highly preferred
- Direct Management experience
Danaher is a global science & technology innovator committed to
helping our customers solve complex challenges and improve quality
of life worldwide. Our world class brands are leaders in some of
the most demanding and attractive industries, including life
sciences, medical diagnostics, dental, environmental and applied
solutions. Our globally diverse team of 71,000 associates is united
by a common culture and operating system, the Danaher Business
System, which serves as our competitive advantage. We generated
$19.9B in revenue last year. We are ranked #162 on the Fortune 500
and our stock has outperformed the S&P 500 by more than 5,200%
over 25 years.
At Danaher, you can build a career in a way no other company can
duplicate. Our brands allow us to offer dynamic careers across
multiple industries. We're innovative, fast-paced,
results-oriented, and we win. We need talented people to keep
winning. Here you'll learn how DBS is used to shape strategy, focus
execution, align our people, and create value for customers and
shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically
has key components including base salary, variable annual incentive
compensation based on personal and company performance, and
When you join us, you'll also be joining Danaher's global
organization, where 69,000 people wake up every day determined to
help our customers win. As an associate, you'll try new things,
work hard, and advance your skills with guidance from dedicated
leaders, all with the support of powerful Danaher Business System
tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to
equal opportunity regardless of race, color, national origin,
religion, sex, age, marital status, disability, veteran status,
sexual orientation, gender identity, or other characteristics
protected by law. We value diversity and the existence of
similarities and differences, both visible and not, found in our
workforce, workplace and throughout the markets we serve. Our
associates, customers and shareholders contribute unique and
different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided
reasonable accommodation to participate in the job application or
interview process, to perform crucial job functions, and to receive
other benefits and privileges of employment. Please contact us at
202.419.7762 or firstname.lastname@example.org to request
If you've ever wondered what's within you, there's no better
time to find out.
Keywords: Danaher, San Jose , Regulatory Affairs Business Process Manager - REMOTE, Other , San Jose, California
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