Principal Regulatory Affairs Specialist
Company: Waters Corporation
Location: Milford
Posted on: March 19, 2023
Job Description:
Overview
The Principal Regulatory Affairs Specialist has primary
responsibility for the determination and execution of In Vitro
Diagnostic regulatory strategy including provision of regulatory
input to new product development teams to ensure product
requirements/design inputs, study design of pre-clinical/clinical
trials and design outputs including assessment of clinical evidence
enable identified planned regulatory filings.
Determine and execute regulatory strategy to expand scope of use
and geographic registration of current Waters IVD portfolio.
Prepare, execute and maintain regulatory filings including change
management, support of post market requirements and support of
outside vendors [e.g. license holders, in country
representatives].
This role reports to the Senior Director, Regulatory and Clinical
Affairs.
The role will work through multiple levels and across functions
within the Clinical Business Unit organization to support the
growth of the IVD product portfolio.
Responsibilities
New Product Development
- Act as Subject Matter Expert (SME) and Regulatory Affairs lead
for the new product development projects, provide "solution-based"
advice to development teams
- Proactively partner with R&D, Marketing, and other groups
to develop and maintain regulatory and clinical strategies for new
and modified product / product families, including expansion of
scope of use and/or geographical areas
- Prepare and execute regulatory filings such as pre-IDEs,
premarket notifications, technical files, Canadian submissions, and
letters to file.
- Conduct international registrations in accordance with and in
support of regulatory strategies
- Provide input on and approve product labels and labelling
including language requirements worldwide
- Evaluate, set up and manage outside vendors such as License
holders, Clinical Research organisations and In Country agents
[including importers, distributors], as needed.
- Perform regulatory research to find predicate and support new
product development as needed
Change Management
- Provide regulatory guidance on changes to existing
products
- Monitor global regulatory intelligence, provide impact
evaluation to changing regulations and mitigation approach
option[s].
- Performing regulatory impact assessments for engineering
changes
- Review and approve promotional materials, -
- Oversee, maintain, and develop departmental policies,
procedures and forms required to ensure compliance with applicable
laws and regulations
External Influence:
- Act as the point of contact with Worldwide Competent
Authorities, Notified Bodies and Authorized
representatives
- Interact with FDA and other global regulatory bodies plus
registration authorities as required to ensure timely, effective
submission
- Manage relationship with international regulatory agencies and
standard bodies, act as Waters representative providing input to
application of existing regulations and proposed changes.
- Maintain up-to-date knowledge of global regulatory requirements
for all countries where product is registered for sale through
regulatory intelligence activities
Post Market
- Provide regulatory input to support post market surveillance
and vigilance activities
- Support Health Hazard Assessments and Field Actions as
needed
Leadership
- Participates in the implementation of Regulatory and Clinical
Affairs strategy and accomplishes the key performance
objectives.
- Promote and generate a strong Quality culture within the
Clinical Business Unit through effective collaboration with
peers.
- Act as Subject Matter Expert within 3rd party and internal
audits
- Mentor to regulatory specialists on regulatory and clinical
affairs requirements and approach.
- Ensure improvements are made in accordance with in accordance
with the requirements of: ISO 9001; ISO 13485; 21 CFR parts 11 and
820.
Individual
- Maintain the effectiveness of the Quality system at the sites
via adherence to applicable policies and procedures
- Complete Quality System related actions in a timely manner
according to procedures e.g. CAPA, NCR
- Adhere to Environmental, Health and Safety policies and
procedures.
Qualifications
Experience Required:
- Minimum of a Bachelors Degree required, Analytical Chemistry,
Biochemistry, or Biomedical Graduate education is
preferable
- Proven significant regulatory affairs experience in the In
Vitro Diagnostic Medical Device environment supporting worldwide
regulatory and clinical strategy for new and changed IVD medical
devices
- Proven experience with the development of multi-geography
regulatory strategies
- Proven experience and understanding of FDA and global
regulations, including China, Europe (IVDR), India, and
Brazil
- First-hand experience with preparation and execution of
regulatory filings such as pre-Submissions, premarket
notifications, & technical files for US & EU regulatory approval,
preferably for clinical IVD products
- Knowledge and application of ISO 9001, ISO 13485, ISO 14971,
ISO 62304, 21 CFR 820, IVDR.
- Experience reviewing clinical/performance evaluation reports
and literature searches/reviews
- Experience managing vendor selection and performance
Experienced Preffered:
- Desirable - knowledge and application of CLSI standards to
assay validation
- Desirable - knowledge of LC/MS and Software as a medical device
(SaMD) regulations
- Desirable - experience of regulatory filings in China,
Australia, Canada
Skills/Aptitude:
- Able to work effectively in a global function
- Ability to manage and influence in a complex, global matrix
organization
- Strong ability to lead staff dispersed across many different
locations and cultures
- Strong organization/prioritization skills
- Outstanding Work Ethic.
- Strong ability to identify and analyze complex problems and
recommend actions.
- Effective communication and influencing skills.
- Strong team orientation and team builder with the ability to
mentor and development members of the team
- Team player demonstrating good organizational and
prioritization skills
- Self-starting demonstrating initiative
Company Description
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. -
Key WordsRegulatory, Specialist, Clinical, IVD, medical
Keywords: Waters Corporation, Milford , Principal Regulatory Affairs Specialist, Other , Milford, Connecticut
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