#x 9; 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 re... more details
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
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