REGULATORY AFFAIRS SPECIALIST

Company: Source One Technical Solutions
Location: Lake Forest
Posted on: October 30, 2024

Job Description:

Source One is a consulting services company and we're currently looking for the following individual to work as a consultant to our direct client, a global medical device company in Lake Forest, CA.
Title: Regulatory Affairs Specialist - ContractorPay Rate: $58.79/hr (W-2)
Job Description:- Compile and maintain regulatory documentation databases or systems.- Coordinate efforts associated with the preparation of regulatory documents or submissions.- Analyze product complaints and make recommendations regarding their reportability.- Develop or conduct employee regulatory training.- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.- Escort government inspectors during inspections and provide post-inspection follow-up information as requested.- Coordinate, prepare, or review regulatory submissions for domestic or international projects.- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.- Maintain a current knowledge base of existing and emerging regulations, standards, or guidance documents.- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.- Participate in internal or external audits.- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.- Prepare or maintain technical files as necessary to obtain and sustain product approval.- Recommend changes to company procedures in response to changes in regulations or standards.- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.- Review clinical protocols to ensure collection of data needed for regulatory submissions.- Write or update standard operating procedures, work instructions, or policies.- Coordinate recall or market withdrawal activities as necessary.- Develop or track quality metrics.- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.- Monitor national or international legislation on ozone-depleting substances or global warming.- Obtain clearances for the use of recycled plastics in product packaging.- Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.- Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
Requirements:- Bachelor's degree- At least 3 years of work experience- Knowledge of US, EU, and Canada Medical Device Regulations- Familiarity with PLM WindChill and Veeva RIM platforms (not a mandatory requirement)

Keywords: Source One Technical Solutions, Placentia , REGULATORY AFFAIRS SPECIALIST, Other , Lake Forest, California