Senior Regulatory Affairs Specialist Job Listing at Kelly Services in Cuyahoga Falls, OH (Job ID 9364489)

Description

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

Direct Hire
Shift: Monday - Friday 8am-5pm 
Hybrid: 2 days remote, 3 days onsite 
Compensation: based on experience 

Responsibilities:

• Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical device and environmental regulatory compliance.
• Assist in maintaining the Quality Management System to ensure domestic and international standards are met.
• Define and document corporate regulatory practices within the Quality Management System to maintain compliance with applicable regulatory agencies.
• Support the development of new and revised products through the analysis of applicable regulations and the creation and implementation of the appropriate regulatory strategies.
• Register new products with the appropriate agencies and organizations and maintain the registrations of existing products according to the applicable regulatory strategies.
• Provide guidance to the Engineering staff on the creation and maintenance of Design History Files (DHF), Device Master Records (DMR) and Technical Files.
• Provide technical assistance to other departments in the determination of testing requirements to comply with medical device and electrical safety regulations.
• Participate in the support of external audits performed by notified bodies, regulatory agencies, customers and business partners.
• Interface with cross-functional teams on large and small projects to ensure products are transferred to production in accordance with cGMPs, QSRs, MDRs and the Quality Management System.
• Review, analyze and approve validations as appropriate.
• Provide assistance interdepartmentally in the formal assessment of risk in accordance to published regulations and/or customer expectations.
• Strive for continuous improvements to the regulatory processes.
• Communicate regularly and effectively with cross-functional personnel in order to achieve desired objectives.
• Complete special projects as assigned by the Quality / Regulatory Manager.
• Adhere to and promote all organizational policies and procedures.
• Other duties as assigned.

Qualifications:

• Bachelor's degree in a science, mathematics, engineering or other technology field
• 5+ years of progressive experience in regulatory affairs required
• Appropriate combination of education and experience may also be acceptable
• Prior knowledge of 21CFR 820, ISO13485, MDR QMS requirements required
• Experience with medical device products required
• Experience with EPA regulations required
• Experience with EU MDR Technical Documentation required
• Experience with 510(k) submissions required
• Experience with Health Canada License submissions and amendments required
• RAPS or other regulatory certifications required
• Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, Power Point, Outlook)
• Problem solving/analysis including statistical process control
• Technical capacity including decision making, communication and reporting
• Strong interpersonal communication skill set
• Organizational skills

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.

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