Regulatory Affairs Specialist

Company: Monster
Location: Glendora
Posted on: February 18, 2021

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