Kelly Services Outsourcing & Consulting Group (OCG) is seeking a Regulatory Specialist for a 2+ year assignment in Somerville, NJ . The Regulatory Specialist is responsible for preparation of the Technical Dossier for registrations to support products from multiple business units in the Medical Device sector of our client for global markets.
Help establish international registration strategies for global markets, including developing submission timelines, capacity planning & prioritization
Supports international tenders, health authority questions and customs-related queries
Prepares common registration dossiers for new products, new registration and changes
Reviews and assesses documentation to ensure correct interpretation of country regulations
Consults with other stakeholders within the organization regarding submission requirements and standards to facilitate efficient processing by agencies.
Integrates and executes results-oriented Regulatory Affairs strategies. Accountable for the achievement of business goals and objectives, based on priorities and considering benefits/risks.
Consistently manages large amounts of changing, complex, and/or ambiguous information
Lead project work within team
Bachelor degree in a technical field or equivalent, Masters degree in technical field highly desirable
5 years experience in medical device/pharmaceutical/consumer sector; 3 years with an advanced degree
Solid knowledge in international regulation and processes; experience in dossier creation
Knowledge in IMDRF Table of Contents highly desirable
Experience in project management
Highly developed communication skills; fluency in written and verbal English is essential
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
This position comes with enhanced benefits which include:
50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*
Paid sick days and vacation days*
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 requirements
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.
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