Regulatory Affairs Specialist

Regulatory Affairs Specialist Apply Now Applied To save a job sign in or get started Job ID: 10246413 Posted today Back Cordova, TN, US Scientific Bachelors Degree Full Time, Temporary $35 - $38 per hour based on experience Experienced (Non-Manager) Remote Medical Devices and Supplies First Shift (Day) Cordova, TN, US $35 - $38 per hour based on experience Experienced (Non-Manager) Full Time, Temporary Medical Devices and Supplies Remote Scientific Bachelors Degree First Shift (Day) Apply Now Applied Job details Job Title: Regulatory Affairs Specialist Location: Memphis, TN preferred, open to remote candidates. Must be in EST/CST time zones Duration: 7 months with possible extensions Pay : $35 - $38 per hour based on experience Position Summary: Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company's product launch timelines in all identified markets. Manage/lead regulatory-driven project, as directed by management. Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology Plan, lead and support for internal and Regulatory agency audits Lead and direct engagement with regulatory authorities as required Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Review product labeling to ensure compliance with regulatory requirements Other activities as assigned. Requirements Manager is looking for someone preferably with EU MDR submission experience. 510k experience is not required but would be an added bonus Interview Process: Teams interview with hiring manager, potentially Project Lead Why Kelly? Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering & scientific talent and services since 1965. And Engineering & Scientific job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests. As a Kelly Services employee, you will have access to numerous perks, including: Exposure to a variety of career opportunities as a result of our expansive network of client companies Career guides, information and tools to help you successfully position yourself throughout every stage of your career Access to more than 3,000 online training courses through our Kelly Learning Center Weekly pay and service bonus plans Group-rate insurance options available immediately upon hire* 10246413 Share this job Copied url To save a job sign in or get started To apply for this job email your details to I want more jobs like this in my inbox. GET JOB ALERTS Share this job Copied url Link Copied Similar Jobs To save a job sign in or get started Accounting Specialist Collierville, TN, US Part Time, Temporary $35 - $38 per hour based on experience 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 Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsit's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. 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 lifejust 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. Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice .