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19 days old

Regulatory Affairs Specialist

Kelly Services
Irvine, CA 92604
Kelly Science and Clinical FSP is currently seeking a Regulatory Affairs Specialist for a long-term engagement in (location) with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within our clients company, is seeking a Regulatory Affairs Specialist for International Registration, as part of the Regulatory Affairs International team, located in Irvine, CA.


The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Electrophysiology (EP), Neurovascular, Breast Aesthetics, and Reprocessing.


The Regulatory Affairs Specialist 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.


**RA Specialist Job Duties:**


+ 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.

+ Able to utilize excel applications


**Qualifications**


+ A Bachelors 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


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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 worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits 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** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


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 Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-09 Expires: 2022-10-10

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Regulatory Affairs Specialist

Kelly Services
Irvine, CA 92604

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