Registration/Reg Ops Lead Job Listing at Kelly Services in Irvine, CA (Job ID 9590224)

Description

Job Description: Registration/RegOps Lead

QUALIFICATIONS:         

• Minimum education required:
• • A Bachelor's degree is required in a scientific field
• Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
  •  
  • A minimum of 4 years of related Regulatory experience is required.
  • Experience with medical device registration is required.
  • Excellent technical writing skills required.
  • Analytical thinking, problem solving, and investigative skills are required.
  • Experience in the application of Quality Management System Standard ISO 13485, MDD / MDR, and US FDA regulations
  • Demonstrable track record of successfully managing multiple projects simultaneously is required.
  • Excellent English written and oral communication skills are required.
  • Proficiency in Microsoft Office and all related applications is required.

SUPERVISION/AUTHORITY

1.  

• Gives no supervision to others
• Under general or minimum supervision, performs duties in terms of stated objectives.

JOB GOAL:

• The Registration/RegOps Lead is responsible for compiling the necessary documentation required for a regulatory submission including the generation of the technical content to maintain and obtain global product registrations for EMEA, LATAM and ASPAC for a large-scale new product and lifecycle management project. 

RESPONSIBILITIES:

• Coordinate, compile, author, format and supply the required documentation (including the management of obtaining non-technical documents such as Certificates to Foreign Government, legalized/apostilled documents, etc.) to regulatory teams in Latin America, Asia Pacific, Japan and Europe, Middle East and Africa for product registrations.
• Work with regulatory partners to ensure on time execution and approval of product registrations in Asia Pacific, Europe, Middle East, Africa and Latin America.
• Researches, collects data, and addresses requests from local regulatory teams or regulatory agencies to prepare documentation required for health authority submissions
• Work under minimal supervision, with benefit of previous regulatory experience.
• Requires a general use and application of Regulatory concepts, practices and techniques.
• Develop solutions to a variety of problems of moderate scope and complexity.
• Perform other duties as assigned by the manager of this position. Ensure compliance with applicable international regulations and standards
• Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Assist with responses to health authority questions and other Regulatory correspondence.
• Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
• Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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