Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)
Description:
- 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.
- 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.
- 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.
Skills:
Regulatory affairs, Regulatory, Medical device, Fda, Regulatory submission, Regulatory documents, Regulatory compliance, Iso 13485, Gmp, eu mdr, 21cfr 820, Labelling, Quality assurance, Compliance
Additional Skills & Qualifications:
- Bachelor’s degree in a science, mathematics, engineering or other technology field is preferred.
- 3-5 years of progressive experience in regulatory affairs required
- Prior knowledge of 21CFR 820, ISO13485, MDR QMS requirements required
- Experience with EU MDR Technical Documentation preferre
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0 Regulatory Relations Specialist jobs found in Akron, OH area