Regulatory Affairs Specialist

Regulatory Affairs SpecialistThe Regulatory Affairs Specialist supports the product portfolio, manufacturing operations, customer needs, and P&L objectives by contributing to all phases of the product lifecycle. This role provides regulatory guidance, manages product registrations, evaluates engineering changes for regulatory compliance, maintains required regulatory records and reports, and interacts with regulatory agencies and notified bodies. The specialist applies solid knowledge of the regulatory environment and business principles while working under the direct supervision of the Quality/Regulatory Manager.ResponsibilitiesAssist in establishing and maintaining regulatory functions and systems to ensure continuous compliance with medical device and environmental regulations.Assist in maintaining the Quality Management System (QMS) to ensure domestic and international standards are consistently met.Define and document corporate regulatory practices within the QMS to maintain compliance with applicable regulatory agencies.Support the development of new and revised products by analyzing applicable regulations and creating and implementing appropriate regulatory strategies.Register new products with the appropriate agencies and organizations and maintain registrations of existing products according to approved regulatory strategies.Provide guidance to 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 to determine testing requirements needed to comply with medical device and electrical safety regulations.Participate in and support external audits performed by notified bodies, regulatory agencies, customers, and business partners.Interface with cross-functional teams on projects of varying size to ensure products are transferred to production in accordance with cGMPs, QSRs, MDRs, and the QMS.Review, analyze, and approve validation activities as appropriate to ensure regulatory and quality requirements are met.Provide interdepartmental assistance in the formal assessment of risk in accordance with published regulations and customer expectations.Strive for continuous improvement of regulatory processes and practices.Communicate regularly and effectively with cross-functional personnel to achieve regulatory and business objectives.Complete special projects as assigned by the Quality/Regulatory Manager.Adhere to and promote all organizational policies and procedures.Essential Skills5+ years of progressive experience in regulatory affairs.Experience in regulatory affairs related to medical devices, including regulatory submissions and regulatory documentation.Working knowledge of regulatory compliance requirements for medical devices and environmental regulations.Proficiency in Microsoft Office Suite, including Word, Excel, Project, Visio, PowerPoint, and Outlook.Strong problem-solving and analysis skills, including familiarity with statistical process control.Technical capacity with sound decision-making, clear communication, and accurate reporting.Strong interpersonal communication skills with the ability to collaborate across functions.Solid organizational skills with the ability to manage multiple tasks and priorities.Appropriate combination of education and experience in regulatory affairs.Additional Skills & QualificationsBachelor's degree in a science, mathematics, engineering, or other technology field is preferred.Prior knowledge of 21 CFR 820, ISO 13485, and MDR quality management system requirements is preferred.Experience with medical device products is preferred.Experience with EPA regulations is preferred.Experience with EU MDR Technical Documentation is preferred.Experience with 510(k) submissions is preferred.Experience with Health Canada licence submissions and amendments is preferred.RAPS or other regulatory certifications are preferred.Work EnvironmentThis is a full-time contract position requiring at least 40 hours per week. The role can be performed fully remotely, offering flexibility in work location. Hours of work and scheduled days are determined by the Director of Regulatory/Quality, with occasional special circumstances that may require off-shift or weekend work. The position involves regular collaboration with cross-functional teams and interaction with regulatory agencies, notified bodies, customers, and business partners, primarily through digital communication tools and standard office software.Job Type & LocationThis is a Contract position based out of Cuyahoga Falls, OH.Pay and BenefitsThe pay range for this position is $30.00 - $40.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully remote position.Application DeadlineThis position is anticipated to close on Sep 11, 2026.