Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Regulatory Specialist

Expired Job

Kelly Services Somerville , NJ 08876

Posted 5 months ago

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.

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:

  • 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 holidays

  • 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

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


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Regulatory Affairs Program Lead

Johnson & Johnson

Posted 2 days ago

VIEW JOBS 1/15/2019 12:00:00 AM 2019-04-15T00:00 Johnson & Johnson's Family ofCompanies is recruiting for a SeniorRegulatory Affairs Program Lead. This position will sit in Somerville,NJ and support our Medical Device business. The Johnson & Johnson MedicalDevices Companies have been working to make surgery better for more than acentury. With substantial breadth and depth in surgical technologies,orthopedic and interventional solutions, we aspire to improve and enhancemedical care for people worldwide. Together, we are working to shape the futureof health through differentiated products and services. The Senior Regulatory Affairs Program Lead provides regulatoryguidance and leadership to project teams in strategic planning and relatedsubmissions to support Ethicon Wound Closure & Repair (WC&R) andBiosurgery products. Under minimal supervision, the individual leads thesubmission of MDD renewals and MDR registrations to allow continued marketingof products in key countries. The Lead helps to define data and informationneeded for regulatory actions in conjunction with cross-functional teams.He/she will guide MDR compliance activities ensuring effective transition ofregulatory files and preparation for related audits. The Ethicon business offers a broadrange of products, platforms and technologies—including sutures, surgicalstaplers, clip appliers, trocars and synthetic mesh devices—that are used in awide variety of minimally invasive and open surgical procedures. Specialtiesinclude support for treatment of colorectal and thoracic conditions, women'shealth conditions, hernias, cancer and obesity. The Ethicon business combinesproducts and services of two market leading legacy companies, both with longhistories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey,was founded more than 80 years ago as a pioneer in suture development andmanufacturing, helping to transform the safety and electiveness of opensurgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati,Ohio, developing innovative devices that have driven the revolutionary shiftfrom open to minimally invasive surgery that continues to lead the industrytoday. Inthis role, you will: * Represent Regulatory Affairs on cross-functional project teams * Demonstrate the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives. * Consult with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions. * Provide support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. * Make decisions with guidance in ambiguous or unclear situations. * Be responsible for supporting registration activities that initiate and maintain international product approvals. * Provide independent strategic regulatory knowledge to business partners related to submissions to support optimal timelines for new and modified product launches. * Define data and information needed for regulatory approvals. * Plan schedules for regulatory deliverables on a project and monitors project through completion. * Provide Regulatory Affairs support and strategy during internal and external audits. * Drive forward the improvement of creative practices and processes. Qualifications * A Bachelor's degree (science or technical discipline is preferred) with a minimum of 5 years of regulatory or compliance related work experience is required. * Medical Device regulatory experience is required. * Experience 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. * Demonstrable track of successfully managing multiple projects simultaneously is required. * Excellent written and oral communication skills are required. * Good analytical thinking, problem solving, and investigative skills are required. * Ability to lead others. * Strong Project Management skills is preferred. * Proficiency in Microsoft Office and all related applications is required. * This position will be based in Somerville, NJ and may require up to 10% domestic and/or international travel. Johnson & Johnson is anAffirmative Action and Equal Opportunity Employer. All qualified applicantswill receive consideration for employment without regard to race, color,religion, sex, sexual orientation, gender identity, age, national origin, orprotected veteran status and will not be discriminated against on the basis ofdisability. Primary Location United States-New Jersey-Somerville- Organization Depuy Orthopaedics. Inc. (6029) Job Function Regulatory Affairs Requisition ID 3782190110 Johnson & Johnson Somerville NJ

Regulatory Specialist

Expired Job

Kelly Services