Senior Director, Global Regulatory Affairs

Job Title: Senior Director, Global Regulatory Affairs

Role Level: People Manager

Supervisor/Manager Title: Vice President, Regulatory Affairs

Job Location & Environment: Irvine, CA – Corporate Environment

Job Description Summary: Manages global regulatory affairs communication, filing strategy, regulatory negotiation and correspondence tracking, submission development, query response development and other assigned activities for all JenaValve products. Provides expertise in translating regulatory requirements into practical, workable plans. Develops and implements strategies for the earliest possible approvals of regulatory applications. Provides counsel to and manages direct report(s). Ensures timely preparation of organized and scientifically valid submissions. Interacts with internal departments and external representatives (i.e., distributors, legal agents, regulatory agencies).

Job Responsibilities

• Directs, manages, and oversees the Regulatory Affairs department and processes.
• Regulatory Submissions: Ensures the preparation of high-quality global filings for investigational device authorizations, product registrations, process improvements, periodic reports, and amendments/supplements. Coordinates closely with applicable regulatory authorities/agencies to ensure alignment and clarity.
• Management/Supervision: Manages RA staff and develops personnel. Creates and updates departmental procedures as required.
• Communication: Manages communication and relationships with JenaValve Leeds and Munich personnel, US and global regulators, legal agents, distributor partners, and suppliers on project­ related activities necessary to ensure appropriate regulatory approvals are in place in covered regions.
• Project Teams: Leads (or assigns) regulatory team support to product development and sustaining teams, providing clear direction and input to assure that applicable global requirements are incorporated as part of the development process and to drive attainment of company objectives.
• External Standards: Manages the company's processes to ensure all relevant external standards are identified, assessed, and interpreted, and gap analyses are documented and driven to closure.
• Marketing Materials: Reviews and approved marketing materials for compliance with labeling and regulatory requirements.
• Quality System Support: Reviews and approves risk management activities, test protocols and reports, NCRs, CAPAs, and other technical documents. Reviews and approves document change orders (DCOs) and documents the global regulatory impact.
• Adverse Event Reporting: Ensures timely, effective review of information, and reporting to regulatory authorities (e.g., Medical Device Reports (MDRs), Vigilance reports, field safety notices, and other communication) and stakeholders.
• Audits: Supports internal and external audits as required.
• Produces periodic dashboards and reports on global activities, issues, recommendations, and plans going forward.
• Performs other duties as assigned by supervisor.
  
  

Qualifications

Required Education and Experience:

• Bachelor's degree in a scientific discipline or equivalent is required.
• Minimum of 10-15 years in Class III medical device Regulatory Affairs and/or Quality and/or Product Development.
• Experience managing personnel and project teams.
• Comprehensive knowledge of global medical device regulations, quality systems and relationship to business activities.
• Demonstrated ability to interpret regulatory standards and guidance documents and provide direction to project teams in a fast-paced, technically challenging environment where drive is critical to success.
  
  

Skills And Abilities Required For This Job

• Self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
• Effective interpersonal skills/diplomacy and problem-solving techniques.
• Excellent applied thinking, technical writing, communication, and organization skills required.
• Strong verbal and written communication, organization, and project management skills required.
• Works on problems of diverse scope and analyzes data and information to make sound decisions, recommendations, and regulatory filings of high quality.
• 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.
  
  

Core Competencies

• Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers' current and future expectations; Respond promptly to customer needs.
• Innovation: Develop and champion unique ideas and solutions; Find new ways to use technology more effectively; Promote continuous learning.
• Interdependent Partnering: Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.
• Master Complexity: Competently handle day-to-day work challenges; Thrive in uncertain circumstances; Adapt to changes in the work environment; Manage multiple tasks and competing demands; Change approach or method to best fit the situation.
• Organizational & People Development: Function as both team player and leader; Provide informal feedback; Challenge the status quo; Strive for continuous professional development; Recognize the contributions of others; Set and achieve challenging goals.
• Spoken Communication: Speak clearly and concisely; Listen carefully and seek clarification; Deliver effective presentations.
• Written Communication: Write clearly and informatively; Create documents that are complete and accurate.
• Commitment: Strive to attain quality results on time; Convey a sense of urgency and drive issues to closure; Earn a reputation for reliability and dependability.
• Decisions: Make timely and sound decisions; Take risks and manage them intelligently.
• Problem Solving: Proactively seek solutions; Gather and analyze information systematically; Develop alternative solutions; Think analytically and act decisively.
• Diversity: Respond with sensitivity to people of diverse perspectives, ideas, backgrounds, lifestyles, and ages; Foster open communication and respect for the individual.
• Equipment Use: Copy machines, personal computers, and computer terminals.
• Computer Skills: Software proficiency in Microsoft Office Suite.
• Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference.
• Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral. diagram or schedule form.
  
  

Physical Requirements

• Ability to sit or stand for extended periods while working at a computer or in meetings.
• Up to 20% travel required.
• The employee must occasionally lift and/or move up to 20 pounds.