Senior Manager, Regulatory Affairs

Job Title: Sr. Manager, Regulatory Affairs

Supervisor/Manager Title: VP, Regulatory Affairs

Job Description Summary: 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.