Medical Device, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
Cook Biotech, Inc. develops and manufactures advanced tissue-repair products for patients worldwide.
Essential Job Function/Duties
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, 510(k) Submissions and PMAs for US submissions or the equivalent set of documents for European 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.
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.
Minimum Work Experience/Educational Requirements
Holds a Ph.D. in science or engineering (any additionalMinimum Work Experience/Educational Requirements relevant experience would be very highly considered) or a MS with a minimum of 5 years of 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
Ability to effectively and accurately communicate technical, medical and scientific
Must be self-motivated and able to work with a minimum of supervision either alone or in a team
Must be able to lead others in a positive way in concert with the company’s vision
Telecommuting is allowed. Employer will assist with relocation costs.
Internal Number: 090116
About Cook Biotech
Cook Biotech Inc. develops and manufactures advanced tissue-repair products for patients worldwide. Cook Biotech’s products are derived from proprietary extracellular matrix (ECM) technology using proprietary manufacturing processes. ECM, a naturally occurring biomaterial, possesses tissue-remodeling properties. Cook Biotech products are used to treat multiple types of wounds (e.g., burns, non-healing chronic wounds, diabetic wounds) and for patient treatments including hernia repair, fistula repair, otologic repair, and soft-tissue reinforcement. Cook Biotech sells its ECM products under several brands, including Biodesign® and OASIS®. Cook Biotech is part of the Cook Group, which includes Cook Medical in Bloomington, Indiana. Cook Biotech is located in the Purdue Research Park in West Lafayette, Indiana. It was established in 1995 following a Purdue University biomedical engineering research team’s discovery of the tissue-remodeling properties of ECM. For more information, visit http://www.cookbiotech.com.