SR. REGULATORY SPECIALIST
Company: ProArch Consulting Services
Location: Fremont
Posted on: February 24, 2021
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Job Description:
Company Description:We are a leading manufacturer and supplier
of flow cytometry products and services. Our compact, affordable
instruments and wide ranging support offerings are used by
researchers and clinicians all over the world.Job Location:
Fremont, CaliforniaMAJOR DUTIES AND RESPONSIBILITIES:The Senior
Regulatory Affairs Specialist will review and propose the
Regulatory strategy for our clinical / medical device product
commercialization worldwide based upon current country regulations.
They will define the Regulatory processes at our company and
provide oversight to maintain compliance to Regulatory standards.
They will actively support the creation, review and submission of
our product documentation to worldwide regulatory bodies. This
individual will work closely with the QA and Marketing departments
to ensure compliant business practices. The Senior Regulatory
Affairs Specialist will provide guidance in identifying data
needed; obtaining this data and ensuring that it is effectively
created and presented for the registration of products
worldwide.Core job responsibilities for this function include:*
Define worldwide Clinical Product Regulatory Strategy options for
clinical instrumentation, software and associated reagent
consumables* Determine and communicate submission and approval
requirements for proposed clinical product projects* Compile;
prepare; review and submit regulatory submission to authorities.
Interact with regulatory authorities during the development and
review process to ensure submission approval. Monitor and submit
applicable reports to regulatory authorities* Support R&D
Clinical and Research product development projects in a Regulatory
capacity* Provide regulatory input to product lifecycle planning*
Maintain current knowledge of FDA, CE-IVDR, cFDA, and other
regional regulations to confirm that our strategy is viable and has
a high rate of success. Monitor impact of changing regulations on
submission strategies* Continue to revisit and compare regulatory
outcomes with initial product concepts to make recommendations on
future actions. Monitor applications under regulatory review*
Understand; investigate and evaluate regulatory history/background
of class; disease/ therapeutic/diagnostic context in order to
assess regulatory implications for approval* Determine trade issues
to anticipate regulatory obstacles* Participate in risk-benefit
analysis for regulatory compliance* Assess the acceptability of
quality; preclinical and clinical documentation for submission
filing* Evaluate proposed preclinical; clinical and manufacturing
changes for regulatory filing strategies* Assist compliance with
post market surveillance requirements.* Review and approve
advertising and promotional items to ensure regulatory compliance*
Assess external communications relative to regulations* Review
regulatory aspects of contracts* Assist with label development and
review for compliance before release* Submit and review change
controls to determine the level of change and consequent submission
requirements* Analyze the input of cumulative product changes to
current product submissions* Ensure product safety issues and
product-associated events are reported to regulatory agencies and
brought closure in an expedient manner.* Provide regulatory input
for product recalls and recall communications.* Assist in SOP
development and reviewEDUCATION REQUIREMENTS:Bachelor's Degree in
Regulatory Affairs, Clinical Research, Engineering, Biology,
Chemistry or Biochemistry Desired. Masters degree
preferred.EXPERIENCE QUALIFICATIONS:* A minimum of 5 years
experience in a Regulatory Affairs (RA) capacity required.*
Experience in Medical Device required, particularly with
contributions to 510(k), CE-IVD, CE-IVDR and cFDA submissions.*
Experience working with multi-sub-system clinical diagnostic
equipment including electronic, optical, fluidic, and application
software sub-systems is a plus. * Demonstrated experience with
technical file document creation.* Experience participating in
successful Regulatory body audits and responding to Regulatory body
questions and requests for information.KEY SKILLS AND COMPETENCIES:
* Demonstrated knowledge of IVDD, IVDR, 21CFR Part 820, cFDA, and
510k submission processes and their associated regulations. *
Demonstrated excellent verbal and written communication skills.*
Problem solving, analytical, creativity, and critical thinking
skills.* Skilled with MSOffice Applications, Engineering Change
Order Systems, Device History Files and Records management.
Keywords: ProArch Consulting Services, Fremont , SR. REGULATORY SPECIALIST, Other , Fremont, California
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