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Regulatory Affairs Specialist

Company: Jobot
Location: Irvine
Posted on: November 18, 2021

Job Description:

A bit about us:

New up an coming company making major moves in the medical device industry!

Why join us?

Great pay, benefits and work life balance

Job Details

Is your background a fit? Apply if you meet this criteria:

  • Provides guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to teams for solutions.
  • Represents regulatory affairs on product development and commercialization teams.
  • Ensures compliance with standards and execution of corrective actions and is the liaison with domestic and international customers and vendors.
  • Prepares and oversees documentation packages for submission to global regulatory agencies. Tracks timelines and documents milestone achievements for inclusion in regulatory submissions. Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers and technical files).
  • Assists with customer complaints/CAPA system.
  • Develops risk assessment review process for all marketed devices and implementation of changes to risk management process as needed.
  • Monitors proposed and current US and EU regulations and guidance and advises on the impact of such regulations.
  • Reviews documents for regulatory claims, promotional material, labeling content, product and process changes, and product documentation.
  • Collaborates and takes direction from RA management.
  • Strong working knowledge of US and EU regulations that affect Class III medical devices.
  • Experience working on cross functional projects.
  • Fluent English with strong written and verbal communication skills.
  • Excellent analytical thinking and problem-solving skills.
  • 3 years of experience in a regulatory role or related area.
    Core Competencies:
    • Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
    • Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
    • Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
    • Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
    • Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
    • Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
    • Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
    • Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

Keywords: Jobot, Irvine , Regulatory Affairs Specialist, Other , Irvine, California

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