Regulatory Affairs Specialist
Company: Monster
Location: Glendora
Posted on: February 18, 2021
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Job Description:
Company CultureOasis Medical is committed to a respectful and
purposeful work environment; this includes each team member taking
responsibility for the greater good of the company and its goal to
provide exceptional products and service, and to create a
sustainable future for the company and its employee. Each team
member is expected to strive for excellence in all aspects of their
work as well as engage in actively encouraging their teammates to
also strive for excellence.Job SummaryThe Regulatory
AffairsSpecialist provides administrative and technical support to
ensurecompliance with all FDA and other U.S. and international
regulatory requirements. Essential Job FunctionsReasonable
accommodations may be made to enable individuals with disabilities
to perform the essential functions.Ensure adherence to domestic and
foreign regulations and quality standardsWork with and responds to
inquiries from regulatory agenciesRespond to product questionnaires
from customersProvide support to currently marketed products as
necessary. This includes reviewing labeling, promotional material,
product changes, and determination of change on existing
submissions and creation of submissions for changes requiring
regulatory approvalMaintain technical files in compliance with the
European Medical Device DirectiveDevelop, prepares and submits high
quality technical information for submission in geographies as
assigned. Establish timelines, manages sub-team meetings relevant
to the regulatory processes, and ensures timely
execution.Prepareregulatory information and documents needed for
product import or exportCollaborate with Sales and Marketing
personnel to identify global regulatory requirements for
international product registrationsFacilitate issuance of
certificates of origin and/or conformity as requestedRequest FDA
Certificate to Foreign Government, Certificate of Exportability as
neededSupports QA and QC in developing and executing compliance
activities and corrective actions involving regulatory
authorities;Process document legalization, authentication and
apostille as neededSupport the preparation and submission of
product applications and license amendments to Health CanadaProvide
support, creates and maintains documents, correspondence, and
memorandums pertinent to Quality Assurance and Regulatory Affairs
activitiesMaintain Establishment Registrations, Device Listings and
State LicensesIdentify and implement root cause solutionsIdentify
change and improvement in work processes to promote efficiency as
OASIS growsAdhere to general safety rules, manufacturing
procedures, and quality procedures as applicableExhibit
professional behavior and demeanor at all times; proactively
resolve issues using Best PracticesPerform other duties and
responsibilities as requested or assigned Comply with all Company
policiesExperience/Training/EducationMinimum B.S. in scientific
field, preferably life sciences, engineering or business; Graduate
degree is preferred Minimum 5 years'experience supporting
Regulatory Affairs activity in the manufacturing of sterile,
disposable medical devices or equivalent educationExperience with
maintaining ongoing compliance in a regulated environment,
organizing and maintaining detailed regulatory and quality records
and documentation.Experience conducting internal and external
audits Knowledge/Skills/AbilitiesTechnical: Strong understanding of
FDA Quality System Regulations, Medical Device Directive and ISO
13485 regulations. Experienced in US and international regulatory
filing; Proficient with Microsoft Products: Outlook, Word and
Excel. OASIS Medical is an Equal Opportunity Employer.No third
party responses please.
Keywords: Monster, Glendora , Regulatory Affairs Specialist, Other , Glendora, California
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