Senior Specialist, Regulatory Affairs (THV)

Overview

Salary Range $95,000.00 - $95,000.00 Salary

Position Type Full Time

Education Level 4 Year Degree

Category QA - Quality Control

Description

Job Title: Senior Specialist, Regulatory Affairs

Role Level: Individual Contributor

Supervisor/Manager Title: Senior Manager, Regulatory Affairs

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

Job Description Summary: Responsible for global regulatory affairs communication, regulatory negotiation and correspondence tracking, serious adverse event reporting, post-market surveillance, competitive intelligence, and maintenance of standards program. Under supervision, prepares clinical, pre-market and post-market submissions and query response development and communicates with regulatory authorities and partners. Provides expertise in translating regulatory requirements into practical, workable plans. Provides counsel to project teams as applicable. 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:

• Under supervision, lead the preparation, submission, and maintenance of high-quality global filings for investigational device authorizations and registrations, annual reports, and amendments/supplements, communicating with regulatory authorities as applicable.
• Serve as the regulatory team member of product development and sustaining teams, providing clear direction and input to assure that applicable global requirements are incorporated in the development process and to drive attainment of company objectives.
• 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.
• Review and approve FMEAs/risk analyses, protocols, reports, other technical documents.
• Review product labeling for compliance with global labeling regulations.
• Maintain regulatory intelligence through continuous monitoring of regulatory landscape.
• Review and approve document change orders and prepare letters-to-file.
• Update departmental procedures as required.
• Produce monthly reports on global activities, issues, recommendations, and plans going forward.
• 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 and product development process
• Comprehensive knowledge of quality systems and relationship to business
• Ability to interpret regulatory standards and guidance and provide direction to project teams
• 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 required.
• Minimum of 3 to 5 years in medical device Regulatory Affairs or other relevant experience.
• Experience with US Class III cardiovascular 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.

Physical Requirements:

• Up to 20% travel required and ability to travel OUS.
• Ability to occasionally lift and/or move up to 20 pounds.