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Senior Regulatory Affairs Specialist

Company: The Assistant Company
Location: Henderson
Posted on: May 4, 2020

Job Description:

Department: RA/QA Reports to: President As a Senior Regulatory Affairs Specialist with growing, Class II medical device company, you will be responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues. Specific Duties and Responsibilities: - Leverage a working knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to prepare compliant Regulatory strategies that are aligned with the business objectives of the company, including consideration of the global regulatory environment. - Execute Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status. - Leverage scientific and technical understanding of products under scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products - Effectively manage multiple competing priorities of different functional based on factors such as required regulatory submission due dates, time constraints, urgency, and business need - Develop written technical communications that are clear and tailored to the audience and business need for example, responses to regulators, submission dossiers - Demonstrate the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives. - Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to Private Label commercial partners, advise on the submission strategy - Timely compile materials for license renewals, updates and registrations, Maintain regulatory files/database and chronologies in good order. - Establish and maintain system for tracking changes in documents submitted to agencies or partners - Prepare and Lead with Agencies audits (FDA and Notified bodies) - Review labeling and labels for compliance with regulatory requirements - Review changes to existing products and SOPs to define the requirements for regulatory Requirements with ISO/MDD/Health Canada, and MDSAP - Provide the regulatory reviews of customer complaints and define the regulatory reportability Responsible for timely registration of the facility as a device, cosmetics and OTC, EPA. - Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products - Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes - Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required. Core Job Responsibilities: - Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process. - Complete submissions to FDA, EU and Canada regulatory entities. - Create and maintain product EU technical files. - Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws. - Supervise Regulatory Affairs consultants as required. - Other duties as assigned - Other Responsibilities: - Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents. - If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or Quality Assurance - Maintain corporate confidentiality at all times. - As a member of the Organization, the Senior Regulatory Affairs Specialist agrees to embrace and live out the core values of Organization, specifically to: - Put Customer first - Be open-minded - Collaborate - Maintain a sense of urgency Requirements: - Experience working with medical devices. - Either a Bachelor's Degree with 5+ years experience in regulatory affairs OR - Bachelor's Degree with major in regulatory affairs OR - 2 years in ISO 13485 medical device Regulatory Affairs - Regulatory Affairs Certification (RAC) preferred, not required - Knowledge of US and International medical device regulatory requirements - Experience with Class I and II devices and FDA submissions required - International experience is a plus The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities. info@theassistantcompany.com

Keywords: The Assistant Company, Henderson , Senior Regulatory Affairs Specialist, Other , Henderson, Nevada

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