Writes, reviews, submits and maintains technical documents related to: bench testing pre-clinical testing; clinical evaluations (including published and unpublished scientific articles from various sources); and submissions to regulatory agencies for the primary purpose of gaining approval or clearance to market medical devices. CER expert. Career Grid III.
- Writes clear and accurate descriptions of testing and performance of medical devices suitable for regulatory agency review, including but not limited to: Clinical Evidence Reports (CERs), Investigational Device Exemption (IDE) requests, Biological Safety Evaluation Reports (BSERs), 510(k) submissions and PMAs for US submissions or the equivalent sets of documents for OUS submissions.
- Takes a supportable and defensible position on regulatory matters and writes with compelling logic and in a style appropriate for the reader.
- Reviews the work of peers.
- Prepares documentation for submission to regulatory agencies.
- Maintains records of technical documents sent to regulatory agencies.
- Prepares well-organized, complete, and persuasive position papers/statements where needed.
- Authors responses to regulatory agency questions/deficiencies
- Develops and implements regulatory strategies for new and existing products.
- Serves as a company representative to the FDA and foreign regulatory authorities as required, both internally and externally.
- Assesses new technologies and practices for regulatory impact.
- Works closely with product development, pre-clinical, clinical and research teams.
- Manages projects and assures communications within and between project teams to provide guidance, issue resolution, insight, and strategic decisions.
- Provides well-reasoned and defensible opinion on matters of concern to the company by the application of not only scientific logic, but also judgment, wisdom, reason, practicality and insight.
- Holds a MS in science or engineering (any additional relevant experience would be very highly considered) or a BS with a minimum of 5 years of directly applicable regulatory experience specific to the medical device industry.
- Maintains knowledge of European, federal, state and local requirements applicable to the performance of regulatory affairs tasks related to pre-market submissions for medical devices, with specific expertise in either European or US requirements.
- Excellent oral, written, computer and interpersonal skills.
- Ability to rapidly learn new technical subject matter that may be unrelated to area if formal training.
- Ability to effectively and accurately communicate technical, medical and scientific information.
- Must be self-motivated and able to work with a minimum of supervision either alone or in a team environment.
- Must be able to lead and train others in a positive way in concert with the company’s vision.
- Must be able to perform the essential functions of the job, with or without reasonable accommodations.
- Limited exposure to hazardous chemicals used in the manufacture of the product.
- Physical demands are typical of an office and classroom environment.
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed