Regulatory Specialist / Associate with exeperince in Medical device regulatory filings of
o NPD product
o Change notification for EU
o Technical File
o International registration
?3-5years of exepereince in Medical Quality Engineering
?? Assist in the development, documentation, and implementation of regulatory strategies for new technologies and product modifications to include all applicable regulatory requirements.
? Prepare 510(k), Technical File, CE Mark, and other related regulatory filings.
?Support IDE and PMA submission preparation as requested.
? Collaborate with R&D to determine and execute pre-clinical test plans in support of regulatory submissions.
? Establish and maintain a professional and credible image with FDA, TUV, and other regulatory agencies.
? Provide regulatory affairssupport to design teams and the document control/change request system.
? Maintain superior knowledge of competitive technologies in addition to medical and technical developments related to the Companys products.
? Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities.
? Oversee the submission of International Registration Documents, progress reports, supplements and amendments.
? Act as liaison with Covidien International regulatory personnel to address questions and issues that arise as part of the registration and/or testing process.
? Obtain and maintain CFGs including the notarization and legalization, EC/ISO Certs and various other regulatory documents.
? Maintain and update TRAIN database (used for tracking of international registration requests) as administrator .
? Organize regulatory information resources and track and control submissions.
? Provide status information to regulatory management as required
? Ensure the timely and accurate filing of regulatory documentation.
? Develop and maintain product technical files.
? Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
? Participate in compliance activities that relate to the department and the company as a whole.
? Perform other regulatory affairs duties when requested.
? May have to travelinternationally.
?Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents (e-CTD).
? Submissions are produced with electronic publishing tools in compliance with document management standards.
?Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
? Ensure continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
? Prepare, submit, track, index and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse eventreporting, and promotional materials.
? Knowledge in computerized systems.
? Technical writing skills.
??Experience with data analysis/statistical such as MiniTab or equivalent
?Ability to perform all assigned tasks, work independently, and complete work on schedule
?Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization
?Strong problem solving skills and efficient management of time and resources
Regulatory Affairs (RA) Specialist / Regulatory Affairs (RA) Associate