Overview

Our client is a leading manufacturer of medical devices and disposable medical equipment. They are in need of a Regulatory Affairs Specialist to support the product portfolio, manufacturing operations, customer needs and P & L objectives of the company by contributing to all phases of the product lifecycle as required. This includes providing regulatory guidance, registering products, evaluating engineering changes with respect to regulatory compliance, maintaining required regulatory records and reports and interacting with regulatory agencies and notified bodies. This individual will be expected to utilize semi-advanced knowledge of the regulatory environment and business principles while soliciting assistance from more senior regulatory staff members and working under the direct supervision of the Director of Regulatory / R&D.

Job Requirements:

  • 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.
  • Analyze complaints regularly for trends to determine improvements to Design and Safety.
  • Evaluate adverse event complaints that may need reported to applicable agencies.
  • Participate in the support of external audits performed by notified bodies, regulatory agencies, customers and business partners.
  • Participate as a QMS internal auditor to maintain ISO13485 compliance.
  • 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 Director of Regulatory / R&D.
  • Adhere to and promote all organizational policies and procedures.

Qualifications:

  • Bachelor’s degree in a science, mathematics, engineering or other technology field is required
  • 1-3 years of progressive experience in regulatory affairs required
  • Appropriate combination of education and experience may also be acceptable
  • Prior knowledge of 21CFR 820, ISO13485, MDD and MDR QMS requirements preferred
  • Experience with medical device products preferred
  • Experience with EPA regulations preferred
  • Experience with 510(k) submissions preferred
  • ASQ, Six Sigma, RAPS or other regulatory certifications preferred
  • 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

Tracking

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