Irvine, CA Job Details Full-time $177,500 a year 14 hours ago Qualifications Content creation for technical audiences Project management Cultural competency Team management Task prioritization Biomedical regulatory compliance Technical writing experience within technology Legal compliance General management Cross-functional communication Senior leadership
Manages global regulatory affairs communication, filing strategy, submission development, regulatory negotiation, and query response development. Serve as subject matter expert and regulatory lead for JenaValve transition to EU MDR. Provides expertise in translating regulatory requirements into practical, workable strategy and planning documents. Ensures timely preparation of organized and scientifically valid submissions. Collaborates with JenaValve cross-functional departments to achieve corporate objectives. Interacts directly with regulatory agencies. Leads and develops direct report(s).
Job Responsibilities:
Manage and oversee the preparation of high-quality US and EU filings for commercial and investigational device registrations, annual reports, and amendments/supplements. Serve 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. Collaborate with key stakeholders to develop technical, clinical, or labeling content (including R D, Clinical, Marketing, Manufacturing and Quality) to support company objectives and regulatory submissions. Provide coaching and support to direct report(s) and other members of the regulatory department. Communicate 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. Review document change orders for impact on US, EU and international regulatory filings per standard procedures. Interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects, clinical studies, testing, and record keeping. Review and approve marketing and promotional materials for compliance with labeling and regulatory requirements. Support serious adverse event reporting process, Medical Device Reports (MDRs), Vigilance reports, field safety notices, and other communication with regulatory authorities and external stakeholders. Review and approve FMEAs/risk analyses, protocols, reports, NCRs, CAPAs, and other technical documents. Participate in internal audits and external audits as needed. Update and maintain departmental procedures as required. Perform other duties as assigned.
Required Education and Experience:
Bachelor's degree in a scientific discipline (engineering, biology, etc.) or equivalent is required. Minimum of 7 to 10 years in medical device Regulatory Affairs. Minimum of 2 years of direct management experience. Minimum experience of 10 years in medical device industry with Bachelor's degree, minimum experience of 8 years in medical device industry with Master's or other advanced degree. Experience with EU MDR implementation. Experience with US Class
III, IDE
submissions and/or PMA submissions. Experience with cardiovascular devices and transcatheter heart valves preferred. Comprehensive knowledge of quality systems. Experience in applying global medical device regulations and product development process. Ability to interpret regulatory standards and guidance and provide direction to project teams. Skills and Abilities Required for
This Job:
Strong verbal and written communication, organization, and project management skills required, including the ability to influence and to work effectively cross-culturally and cross-functionally. Works on problems of diverse scope and analyzes data and information to make sound decisions, recommendations, and regulatory filings of high quality. Enjoy working in a fast-paced, technically challenging environment where drive is critical to success. Self-motivated and self-disciplined; able to prioritize multiple tasks and responsibilities. Effective interpersonal skills/diplomacy and problem-solving techniques. Excellent applied thinking and technical writing skills. Strong communication and organization skills required. Exercises good judgment within generally defined practices and policies in all aspects of the job. Normally receives no instruction on routine work, and general instructions on new assignments.
