Director - Regulatory and Clinical Affairs
Company: Waters
Location: Raynham
Posted on: June 15, 2022
|
|
Job Description:
Key leadership position for Regulatory and Clinical activities
in support of the In Vitro Diagnostic Clinical business. The role
will be responsible to work through multiple levels within the
organization to influence and driving Waters Regulatory & Clinical
Affairs strategy to support Waters business growth and success.
Ensures all Regulatory and Clinical documentation is for global
registration and maintained throughout the product life cycle. This
role will report directly to the Vice President, Quality Assurance,
Regulatory Affairs and Clinical Affairs. - This role leads a Global
team of Regulatory Affairs professionals with Clinical Affairs
activities included as part of the Waters Clinical Business Unit. -
Strategic Activities: - - -Lead the Global Regulatory & Clinical
Affairs function for Waters Corporation, with emphasis on global
strategy for in vitro diagnostic clinical business activities - -
-Monitor trends and changes in regulations and advise internal
stakeholders on the potential impact to current and future strategy
and tactics - - Provide strategy and review for clinical study
protocols, labeling, and integrated summary documents based on risk
and all unique country requirements - - Proactively partner with
R&D, Marketing, and other groups to provide regulatory advice
and guidance on meeting necessary requirements to place products on
the market globally - - -Develop and implement regulatory and
clinical policies and procedures aligned with the overall company
strategy and targeted to meet desired risk as a business. - - Core
Activities: - - Direct day to day regulatory affairs activities,
including reviewing promotional materials, participating in
submissions and interaction with regulatory agencies - - -Oversee
the process of preparing product submissions and registrations to
domestic and international regulatory bodies, managing the process
from inception to approval - - Assess regulatory impact of
post-market changes on labeling, promotional materials, design,
materials, manufacturing process, or packaging. - - -Consult with
and manage external regulatory affairs consultants. - - -Maintain
compliance with FDA and global medical device regulations -
External Influence: - - -Interact with FDA and other global
regulatory bodies as required to ensure - - timely, effective
submissions - - -Manage relationship with international regulatory
agencies - - -Maintain up-to-date knowledge of global regulatory
requirements for all countries where product is registered for sale
through regulatory intelligence activities - Other
Responsibilities: - - -Participate in due diligence and integration
activities of domestic or foreign acquisitions that have regulatory
implications - - -Participate in external audits with Clinical or
Regulatory questions or reviews - - -Ensure regulatory and clinical
review of Health Hazard Assessments and support of field actions -
- -Train, mentor and supervise regulatory and clinical employees,
consultants and contractors. maintaining high ethical standards,
positive team spirit and strong participative leadership. - -
Master's degree required preferably in science, engineering or
business. - - - -15+ years regulatory affairs experience with
medical devices. IVD experience a must. - - -Extensive
understanding of FDA and global regulations, including China,
Europe (IVDR), India, and Brazil - - 7+ years managerial experience
- - Experience in establishing, developing, and maintaining
relationships with government authorities and regulatory agencies -
- - -Experience with the development of global regulatory
strategies - - -Ability to manage and influence within a global
matrix organization - - -Highly developed intercultural
competence/awareness - - - Strong team orientation and team builder
with the ability to mentor and development members of the team - -
Effective communication and influencing skill - - - - Operates with
integrity and, transparency - - -Acts as a true company owner to
advance the overall interests of Waters - - -Carries a broad global
perspective of markets, tech, and trends - - -Balances clear
strategic thinking and accountability in execution to deliver
results - - - - - - - - - - - - - - - - - - #LI-CB1 - - - Waters
Corporation (NYSE: WAT), the world's leading specialty measurement
company, has pioneered chromatography, mass spectrometry and
thermal analysis innovations serving the life, materials, and food
sciences for more than 60 years. With more than 7,000 employees
worldwide, Waters operates directly in 35 countries, including 15
manufacturing facilities, with products available in more than 100
countries. Our team focuses on creating business advantages for
laboratory-dependent organizations to enable significant
advancement in healthcare delivery, environmental management, food
safety, and water quality. - - - Working at Waters enables our
employees to unlock the potential of their careers. Our global team
is driven by purpose. We strive to be better, learn and improve
every day in everything we do. We're the problem solvers and
innovators that aren't afraid to take risks to transform the world
of human health and well-being. We're all in it together delivering
benefit as one to provide the insights needed today in order to
solve the challenges of tomorrow. - - - - Diversity and inclusion
are fundamental to our core values at Waters Corporation. It is our
responsibility to actively implement programs and practices to
drive inclusive behavior and increase diversity across the
organization. We are united by diversity and thrive on it for the
benefit of our employees, our products, our customers and our
community. Waters is proud to be an equal opportunity workplace and
is an affirmative action employer. We are committed to equal
employment opportunity regardless of race, color, religion, sex,
national origin, sexual orientation, age, marital status,
disability, gender identity or protected Veteran status.
Keywords: Waters, Brockton , Director - Regulatory and Clinical Affairs, Executive , Raynham, Massachusetts
Click
here to apply!
|