Kelly Services Regulatory Affairs Specialist in Sommerville, New Jersey

Regulatory Specialist

Location: Somerville, NJ

Duration: 2 year+ contract

Responsible for preparation of Technical Dossier for registrations to support products from multiple business units in the Medical Device sector of our client for global markets.

Major activities:

  • 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

Qualifications (Education & Experience Requirements):

  • Bachelor degree in a technical field or equivalent, Master’s degree in technical field highly desirable

  • Advanced degree + 3 years´ experience or 5 years´ experience in medical device/pharmaceutical/consumer sector.

  • Solid knowledge in international Regulation and Processes; previous experience in dossier creation highly desirable

  • Knowledge in IMDRF Table of Contents highly desirable

  • Experience in project management

  • Highly developed communication skills

Competencies:

  • Live Our Credo: Demonstrate and inspire the behaviors that reinforce Our Credo.

  • Connect: Encourage and support internal collaboration across levels, creating effective solutions.

  • Shape: Challenge the status quo and adapting to change.

  • Lead: Leverage diverse perspectives, background and talent to generate effective ideas or solutions

  • Deliver: Act with speed, flexibility, accountability and appropriately managing priorities to deliver results whilst remaining calm, professional, diplomatic and positive.

  • Receptive to cultural differences across regions and countries

  • Can thrive in a changing environment Is solution-oriented

  • Fluency in written and verbal English essential

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