Remote Cardiovascular Medical Science Liaison Jobs in Riverside, CA

Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $130,000.00 - $140,000.00 SalaryJob Title: Project Manager, Regulatory Affairs   Supervisor/Manager Title: Senior Manager, Regulatory Affairs   Job Location & Environment: Remote   Job Description Summary: Responsible for timely preparation and submission of organized, scientifically valid global regulatory affairs submissions (clinical, pre-, and post-market applications), query responses and correspondence tracking.  Maintains regulatory information for competitive intelligence, literature maintenance, and standards review programs. Interacts with internal departments and external representatives (i.e., distributors, legal agents, regulatory agencies). Provides expertise in translating regulatory requirements into practical, workable strategy and planning documents. Provides counsel to project team members and regulatory affairs staff as applicable.  Supports serious adverse event reporting, and completion of post-market surveillance activities (complaints, MDR and vigilance reports). Performs other projects and duties as assigned.   Job Responsibilities: \tPrepare timely, high-quality, technical documentation and regulatory submissions for investigational device applications, commercial registrations, annual reports, and amendments/supplements. \tServe as a regulatory team member of product development and sustaining teams, providing clear, concise regulatory strategy to ensure applicable global requirements are met for product development and quality system projects.   \tCollaborate with key stakeholders to develop technical, clinical, or labeling content (including Clinical Operations, Marketing, R&D, Manufacturing and Quality) to support company objectives and regulatory submissions. \tProvide coaching and support to other members of the regulatory department. \tCommunicate with regulatory bodies, legal agents, distributor partners, and suppliers on project-related activities necessary to ensure appropriate regulatory approvals are in place in covered regions. \tReview document change orders for impact on US, EU and international regulatory filings per standard procedures. \tManage standards review process and assist company SME’s to interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects, clinical studies, testing, and record keeping. \tSupport serious adverse event reporting process, Medical Device Reports (MDRs), Vigilance reports, field safety notices, and other communication with regulatory authorities and external stakeholders.  \tReview and approve FMEAs/risk analyses, protocols, reports, NCRs, CAPAs, and other technical documents. \tParticipate in internal audits and external audits as needed.  \tUpdate and maintain departmental procedures as required. \tPerform other duties as assigned. Qualifications  Required Education and Experience: \tBachelor’s degree in a scientific discipline (engineering, biology, etc.) or equivalent is required. \tMinimum of 5 to 8 years in medical device Regulatory Affairs. \tExperience with US Class III cardiovascular devices preferred. \tExperience with EU MDR implementation preferred. \tComprehensive knowledge of quality systems and relationship to business. \tExperience in applying global medical device regulations and product development process. \tAbility to interpret regulatory standards and guidance and provide direction to project teams. \tAbility to work in a fast-paced, technically challenging environment where drive is critical to success. \tSelf-motivated and self-disciplined; able to prioritize multiple tasks and responsibilities. \tEffective interpersonal skills/diplomacy and problem-solving techniques. \tExcellent applied thinking and technical writing skills. \tStrong communication and organization skills required.   Skills and Abilities Required for This Job: \tStrong verbal and written communication, organization, and project management skills required. \tWorks on problems of diverse scope and analyzes data and information to make sound decisions, recommendations, and regulatory filings of high quality. \tSelf-directed with minimum instruction on routine work, and general instruction on new assignments. \tAbility to handle challenges and uncertain circumstances, with adaptability to shifting company priorities. \tExercises good judgment within generally defined practices and policies in all aspects of the job. \tDiplomacy and cultural sensitivity are essential attributes. \tSoftware proficiency in Microsoft Office Suite. \tThe employee must occasionally lift and/or move up to 20 pounds.   Physical Requirements: \tAbility to travel up to 20%.