Location: Dallas, TX
Our client is a reputable, fast growing, Class-III multinational medical device company. They are looking for an experienced, full time Regulatory Affairs Specialist to be based their Dallas TX office. Salary is 130-150k base.
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners; advise on the submission strategy
- Write and assemble Regulatory Submissions for USA, and Canada including PMA, 510(k), pre-PMA, pre- IDE, Technical Files and Application for Investigational Testing for all type of devices;
- Broad experience in Clinical Trial Design, Monitoring and preparation of submissions for Clinical Studies;
- Proven ability to effectively manage multiple projects simultaneously, e.g. clinical trial management and submissions.
- Compile materials for license renewals, Device Annual reports, updates and registrations in a timely manner
- Review labeling and labels for compliance with regulatory requirements
- Review changes to existing products and SOPs to define the requirements for regulatory submissions
- Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes
- Participate in research of regulatory issues and dissemination of regulatory information to Production, QA/QC and R&D departments and senior management as required
- Provide guidance of the Process and Design Controls (Design and Development Planning, Design Input and Output, Design Review, Verification & Validation, Design transfer, Design changes) to the R&D core teams – As needed.
- Participate in the review of product development assuring appropriate regulatory, quality and reliability requirements are defined.
- Responsible to ensure appropriate regulatory standards are correctly established and implemented with adequate evidence of including supporting test documents.
- Participate in the review of clinical relevant test methods and Design Verification and Validation test plans, execution and reports as required
- Participate in the maintenance of technical files relevant to various external agencies and regulatory bodies.
- Ensure that all aspects of Regulatory Compliance and Quality Assurance of the DHF and other program files are met and findings are appropriately addressed in full compliance to regulations and delivery of quality product.
- Support all external/internal audits.
Required Knowledge and Skills:
- Experience with FDA Class III and/or Class-II devices is mandatory
- Requires a degree
- 5 or more years of experience with Regulatory Submissions for USA, and Canada including PMA, 510(k), pre-PMA, pre- IDE, Technical Files and Application for Investigational testing for all types of devices
- Knowledge of USA and international medical device regulatory requirements
- Able to demonstrate very good regulatory writing and submissions to regulatory agencies
- Ability to support several projects simultaneously with a flexible working style and attention to detail
- Able to travel internationally
Please send you CV and application to