Regulatory Affairs Specialist

Regulatory Affairs Specialist

The Regulatory Affairs Specialist II, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with U.S. and international regulatory requirements. The Regulatory Affairs Specialist provides direct Worldwide Regulatory support to lifecycle management and new product development/new product introduction international product registrations.,

The Regulatory Specialist II, will:

• Coordinate, compile, and submit Regulatory documents to competent authorities, notified bodies, Regulatory Agencies, and international business partners. Includes the preparation of key market international documents, including Technical Files.

• Work with Management to ensure rapid and timely approval of new products and continued Regulatory support of products marketed outside the United States.

• Create detailed international regulatory plans in concert with regional Regulatory contacts.

• Evaluate proposed product modifications for international Regulatory impact, completing Regulatory Assessments as needed.

• 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.

• Update and maintain product eligibility to ensure right product/right country.

• Requires use and application of Regulatory concepts, practices and techniques.

• Provide solutions to extremely complex problems.

• Provide regulatory guidance to project teams, as applicable.

• Participate in the review and approval of international product labeling.

• Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.

Qualifications

• A Bachelor's degree is required, preferably in a science or technical discipline. A minimum of 4 years of related Regulatory experience is required.

• Familiarity with Title 21 of the US Code of Federal Regulations Parts 800-1299 (21 CFR 800-1299)

• Experience in the application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is preferred.

• Familiarity in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) and CE marking is required; EU MDR familiarity is preferred.

• Experience in the application of Quality Management System Standard ISO 13485.

• Direct experience with international medical device registration is required.

• Experience with change assessments for internationally marketed medical devices is preferred.

• Demonstrable track of successfully managing multiple projects simultaneously is required.

• Previous experience working with globally dispersed affiliates and stakeholders is preferred.

• Excellent English written and oral communication skills are required.

• Good analytical thinking, problem solving, and investigative skills are required.

• Ability to lead others.

• Proficiency in Microsoft Office and all related applications is required.

• This position will be based in Irvine, CA

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 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.