Manager, Regulatory Affairs (International)

Job Title: Manager, Regulatory Affairs (International)

Supervisor/Manager Title: VP, Regulatory Affairs

Job Location & Environment: Irvine, CA – Corporate Office Environment

Job Description Summary: Manages global regulatory affairs communication, filing strategy, submission development, regulatory negotiation, and query response development for JenaValve with focus on transcatheter heart valve system devices. Serve as subject matter expert for OUS geographies. Provides expertise in translating regulatory requirements into practical, workable strategy and planning documents. Ensures timely preparation of organized and scientifically valid submissions based on needs of internal and external stakeholders. Collaborate with JenaValve’s cross-functional departments to achieve corporate objectives. Interacts directly with external representatives (i.e., regulatory agencies, suppliers, distributors). Leads and develops direct report(s).

Job Responsibilities:

• Manage and oversee the preparation of high-quality global filings for commercial and investigational device registrations, annual reports, and amendments/supplements. Manage rest of world (all geographies outside the US & EU).
• 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 per standard procedures.
• 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. May anticipate and advise on future regulatory trends and direction and recommend preemptive approaches for company regulatory compliance.
• Review and approve marketing and promotional materials for compliance with labeling and regulatory requirements for the appropriate market.
• 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 to support expansion into new markets.
• Perform other duties as assigned.