Sr. Regulatory Affairs Specialist (closed)
Position provides regulatory expertise for the Smiths Medical site based in St. Paul, Minnesota. The incumbent will also be required to provide regulatory advice and assistance to other Smiths Medical site representatives. This will require travel from time to time to effectively carry out these duties. Prepare and submit regulatory submissions to Regulatory Authorities eg the FDA, for PMAA, IDE, 510k Notification and to European notified body to support distribution and marketing objective set by divisional and corporate staff.
- Ensure regulatory compliance to FDA and international regulations.
- Prepare and submit 510(k) Premarket Notification, PMA, IDE, and Design Dossier submissions as directed.
- Create and maintain Essential Requirements Checklists, CE Technical Files and Declarations of Conformity for all products bearing the CE Marking.
- Prepare Annual PMA Report and associated PMA Supplements as required.
- Regulatory representative on new product development teams.
- Review and approve ECO's for product changes and/or modifications related to manufacturability and/or material modifications. Ensure compliance to existing regulatory submissions.
- Review and approve technical literature (labeling, IFU’s, manuals, patient guides, etc.), sales and marketing literature, and reimbursement literature related to company products.
- Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements.
Technical Knowledge and Skills:
- Bachelor's degree in Science or Engineering (or related field) from an accredited college or university. A minimum of Seven to ten years direct experience in regulatory affairs (preferably in the medical device/drug or biomedical area).
- Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures. Including but not limited to FDA, PMAA, IDE, 510(k) Notifications, Medical Device Directive, and European Standards.
- Sound knowledge and understanding of how IDE regulated clinical studies are performed.
- Knowledge and ability to review and approve ECO's and corporate SOP's.
- Sound knowledge and understanding of company products as they relate to medical device law and international medical devise requirements.
- Knowledge and ability to develop, review and approve technical literature as it relates to product specifications and that is consistent with domestic and international regulations.
- Effective facilitation skills to motivate engineers, marketing personnel and/or clinical staff to deliver information related to submission preparation and/or direct product literature review, both technical and sales marketing pieces.
- Proven effective leadership skills to guide, mentor, and develop staff members to perform under stress to meet or exceed project schedules and corporate filing deadlines.
- Excellent verbal, written, and presentation communication skills.