Regulatory Affairs Specialist Job Listing at Kelly Services in Cuyahoga Falls, OH (Job ID US3530565_BH9716274)

Description

Kelly Science & Clinical is seeking a Regulatory Affairs Specialist near Cuyahoga Falls, OH.

Temp to Hire
Shift: Monday - Friday 8am-5pm
Compensation: based on experience


Job Summary: The Regulatory Affairs Specialist will support the product portfolio, manufacturing operations, customer needs, and P & L objectives of our company. This role encompasses contributing to all phases of the product lifecycle, providing regulatory guidance, registering products, evaluating engineering changes for regulatory compliance, maintaining regulatory records and reports, and interacting with regulatory agencies and notified bodies. The Specialist will apply semi-advanced knowledge of the regulatory environment and business principles while seeking guidance from senior regulatory staff and working under the direct supervision of the Quality / Regulatory Manager. Duties and Responsibilities:

• Establish and maintain regulatory functions and systems ensuring continuous medical device and environmental regulatory compliance.
• Maintain the Quality Management System to meet domestic and international standards.
• Document corporate regulatory practices within the Quality Management System to ensure compliance with applicable regulatory agencies.
• Support the development of new and revised products through regulation analysis and strategy implementation.
• Register new products and maintain registrations per regulatory strategies.
• Guide Engineering staff on creating and maintaining Design History Files (DHF), Device Master Records (DMR), and Technical Files.
• Assist other departments in determining testing requirements for medical device and electrical safety regulations compliance.
• Support external audits by notified bodies, regulatory agencies, customers, and business partners.
• Interface with cross-functional teams on projects ensuring products are transferred to production in accordance with cGMPs, QSRs, MDRs and the Quality Management System.
• Review, analyze, and approve validations as appropriate.
• Assist in risk assessment according to published regulations and customer expectations.
• Continuously improve regulatory processes.
• Communicate effectively with cross-functional personnel to achieve objectives.
• Complete special projects as assigned by the Quality / Regulatory Manager.
• Adhere to and promote all organizational policies and procedures.

Qualifications:

• Bachelor's degree in science, mathematics, engineering, or other technology field preferred.
• 1-3 years of experience in regulatory affairs required.
• Combination of education and experience may be acceptable.
• Knowledge of 21CFR 820, ISO13485, MDR QMS requirements preferred.
• Experience with medical device products, EPA regulations, EU MDR Technical Documentation, 510(k) submissions, and Health Canada Licence submissions and amendments preferred.
• RAPS or other regulatory certifications preferred.
• Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, PowerPoint, Outlook).
• Strong problem-solving, analysis, and technical decision-making skills.
• Strong interpersonal communication and organizational skills.

Working Conditions:

• Work in both office and plant environments with varying noise levels.
• Full-time exempt position requiring at least 40 hours per week, with occasional off-shift and weekend work.
• Minimal travel required, including some international travel.

Physical Requirements:

• Frequent desk work with occasional standing and walking to the manufacturing area.
• Required to handle or feel objects, tools, or controls; reach with hands and arms; talk or hear.
• Occasionally lift and/or move up to 50 pounds.
• Regular and consistent attendance at the facility.

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 goals—it'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 life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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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