Regulatory Affairs Specialist Job Listing at Kelly Services in Beachwood, OH (Job ID US3615354_BH10001232)

Description

Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!

Title: Regulatory Affairs Specialist
Location: Cleveland, OH / Beachwood, OH
Duration: 12 months +        
Type: W2 contract (NO C2C OR THIRD PARTY)
Pay: $40.00 - $47.60/hour


Overview

• Join our innovative team in creating the factory of the future for healthcare imaging components.
• We're dedicated to developing and integrating custom software for manufacturing equipment and data collection, enabling advanced analytics and data-driven insights.
• Our mission is to enhance product quality and reduce costs through digital solutions.

Responsibilities

• Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.
• Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc.), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
• Works with a cross functional team to prepare and submit regulatory submissions such as 510(k)s, MDR EU Technical Files, or submissions to other global regulators such as NMPA, TGA, etc., for the purpose of obtaining authorization for market launch.
• Assesses changes in existing products to and determines the need for new / revised licenses or registrations. Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
• Contributes to writing and editing technical documents.
• Researches, analyzes, integrates, and organizes background information from diverse sources for regulatory submissions.
• Ensures compliance with pre- and post-market product approval requirements
• Supports regulatory inspections, as required.

Required Qualifications

• Bachelor's degree from an accredited university or college, preferred in a Scientific, Engineering, Regulatory, Legal, or core Life Science discipline.
• Minimum of 4+ years' experience in a highly regulated industry, preferred in Regulatory Affairs, or equivalent experience through advanced degree or other relevant education and experience.
• Strong verbal and written communication, and presentation skills, with the ability to speak and write clearly and convincingly in English.
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications.

Preferred Qualifications

• Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
• Preferably, Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
• Experience in medical device regulatory affairs
• Demonstrated life-long learner; eagerness to obtain new skills and knowledge.

Additional Information

• Hybrid / Monday – Friday / Onsite 3 days a week
• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Taryn Carbone (taryn.carbone@kellyengineering.com) for immediate consideration.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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