Regulatory Affairs Specialist
Our client, an autoimmune disease diagnostics company is seeking a Regulatory Affairs Specialist to join their team. This is a DIRECT HIRE position.
- Prepare submissions to EU regulatory entities to obtain CE Mark. Create and maintain product EU Technical Files.
- Reviews design history files, device history records and any documentation associated with the development and/or enhancement of product, or requests from appropriate department as needed additional technical documentation, to create/maintain Technical Files and support regulatory filings and CE mark submissions and updates.
- Create and maintain regulatory database.
- Prepare, collect or coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners.
- Review product labeling, advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
- Review product changes to impact on regulatory filings worldwide.
- Provide support in 510(k) submissions if needed.
- Communicates with and fulfill requests from Werfen affiliates and Inova distributors in response to needed documentation to support international regulatory registrations.
- Prepares and coordinates documentation necessary to obtain/renew import/export licenses and related permits.
- Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Min Knowledge & Experience
- Bachelor's degree B.A. or B.S. or equivalent in the biological sciences or related sciences require
- Minimum of 5 years of relevant experience within Regulatory Affairs Discipline preferably in the vitro diagnostics industry.
- Competent in Class II device US regulations (Required
- Knowledge of US and International medical device regulatory requirements.
- Demonstrated experience with ISO and QSRs as applicable to medical devices.
- Experience in creating and maintaining EU Technical files.
- Experience with 510(k) submissions
- Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.