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 - Contractor
Pay 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)
