Senior Specialist, Regulatory Affairs Operations

Job Title: Senior Specialist, Regulatory Affairs Operations

Role Level: Individual Contributor

Supervisor/Manager Title: Senior Manager, Regulatory Affairs

Job Location & Environment: Irvine, CA – Corporate Office

Job Description Summary: The position involves a variety of regulatory operations activities, including technical documentation, GUDID/UDI submissions, and collaboration with cross-functional teams. Responsible for global regulatory affairs communication, correspondence tracking, serious adverse event reporting, post-market surveillance, regulatory intelligence, and maintenance of standards program. Support necessary regulatory activities required for product market entry such as labeling and regulatory shipment authorizations. Interacts with internal departments and external representatives (i.e., distributors, legal agents, regulatory agencies). Provides expertise in translating regulatory requirements into practical, workable plans.

Job Responsibilities

• Review requests for product release and manage regulatory shipment authorizations worldwide to ensure timely delivery of products.
• Support data collection and management for GUDID/UDI submissions in US and international markets.
• Interpret existing or new regulatory requirements as they relate to company products and procedures, labeling, marketing projects, clinical studies, testing, or record keeping.
• Manage and oversee submission of serious adverse event reporting, Medical Device Reports (MDRs), Vigilance reports, field safety notices, and other communication with competent authorities and other external stakeholders.
• Provide formatting and publication expertise to agency submissions.
• Maintain and update assigned standard operating procedures, policies, and user guides as needed.
• Help train on Regulatory Affairs systems and procedures, providing routine problem resolution.
• Review product labeling for compliance with global labeling regulations and support eIFU process.
• Maintain regulatory intelligence through continuous monitoring of regulatory landscape.
• Review and approve document change orders.
• Produce monthly reports on global activities, issues, recommendations, and plans going forward.
• Under supervision, lead the preparation, submission, and maintenance of high-quality global filings for international device authorizations and registrations, annual reports, and amendments/supplements, communicating with regulatory authorities as applicable.
• Participate in external audits as needed.
• Perform other duties as assigned by supervisor.
  
  

Qualifications

Required Education and Experience:

• Experience in applying global medical device regulations.
• Working knowledge of quality systems and relationship to business.
• Ability to work 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.
• Bachelor’s degree in a scientific discipline or equivalent is preferred.
• Minimum of 3 to 5 years in medical device Regulatory Affairs or other relevant experience.
• Experience with US Class III devices preferred.
  
  

Skills And Abilities Required For This Job

• Strong verbal and written communication, organization, and project management skills required.
• Diplomacy and cultural sensitivity are essential attributes.
• 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.
• The employee must occasionally lift and/or move up to 20 pounds.