This position is responsible for providing support for assigned regulatory projects for both internal and external customers.
The Regulatory Specialist will provide support to the functional project teams leading to sound clinical evaluations and successful registration(s) for new and existing products/indications. This role will involve assisting the Regulatory and Clinical Affairs Director with implementing strategic plans to meet business targets, participating and interacting with project groups ensuring MDD/MDR and Regulatory Agency compliance, assisting with clinical and regulatory submissions and departmental projects as assigned
This position offers flexi time/flexibility to work from home on occasion
Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions
Respond to requests from notified bodies, competent authorities and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information
Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products
Reviews proposed labeling/instructions for use for compliance with applicable local and international regulations
Reviews proposed product changes for impact on regulatory status of the product
Designs and Conducts literature searches on products, specific surgical indications, outcomes, or other areas
Supports/Prepares clinical evaluation reports for marketing, regulatory affairs, design review, post-market surveillance, and reimbursement purposes.
Summarizes clinical data and prepares reports, figures, and scientific meeting presentations