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SR. REGULATORY SPECIALIST

Company: ProArch Consulting Services
Location: Fremont
Posted on: February 24, 2021

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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