Vacancy caducado!
Kelly Services’ Outsourcing & Consulting Group (OCG) is seeking a Regulatory Affairs Specialist for a long-term assignment with a client based in Somerville, NJ. The Regulatory Affairs Specialist will provide direct World Wide Regulatory support to various projects and products.This position supports strategic planning and product development efforts and provides Regulatory support for existing products with respect to product changes/modifications. The RA Specialist will ensure compliance with regulatory agency regulations and interpretations, prepares responses to regulatory agencies questions and other correspondence and will assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. In addition the RA Specialist will provide solutions to a variety of problems of moderate scope of complexity, conduct searches of existing files for requested information and will maintain and archive all regulatory documentation.Functional and Technical Competencies:
Leverage a working knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to prepare compliant Regulatory strategies that are aligned with the business objectives of the company, including consideration of the global regulatory environment.
Execute Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status.
Leverage scientific and technical understanding of products under scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products
Effectively manage multiple competing priorities of different functional partners based on factors such as required regulatory submission due dates, time constraints, urgency, and business need
Develop written technical communications that are clear and tailored to the audience and business need for example, responses to regulators, submission dossiers
Demonstrate the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
Qualifications
Minimum of a B.A. /B.S. within a technical related discipline is required.
Minimum of 3 years of experience in Regulatory Affairs or a Master s degree with equivalent experience.
Ability to work both independently and in a team environment.
Ability to problem solve, recognize and find solutions for gaps in processes.
Preferred 510 k submission and CE-marked Design Dossier and Technical File management experience
International regulatory experience desired
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!Perks of being a Kelly employee:
Weekly electronic pay
Access to more than 3,000 online training courses though Kelly Learning center
Online application system
Never an applicant fee
benefits to be received upon meeting eligibility requirementsImportant information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.Why Kelly ® ?The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ® ) is one focus within the full array of Kelly Services® workforce solutions.Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.AboutKelly Services ®As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm