Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (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
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
0 Regulatory Affairs Specialist jobs found in Akron, OH area