Regulatory Affairs Specialist II
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Regulatory Affairs Specialist II
Title:Regulatory Affairs Specialist II
The DAVIS Companies has partnered with a global leader in the medical device industry by securing a Regulatory Affairs Specialist II to join their team.
Responsibilities of Regulatory Affairs Specialist II:
- Prepare and submit regulatory submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510(k) Notification); and to European notified body to support distribution and marketing objective set by divisional and corporate staff.
- Inform project teams of new and changing regulatory requirements.
- Update RA procedures as needed to ensure the company is in compliance with new and changing regulatory requirements.
- Keep abreast of new and changing regulatory requirements.
- Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements.
- 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 ECO's for product changes and/or modifications related to manufacturability and/or material modifications. Ensure compliance to existing regulatory submissions.
- Regulatory representative on new product development teams.
- Prepare Annual PMA Report and associated PMA Supplements as required.
- Create and maintain Essential Requirements Checklists, CE Technical Files and Declarations of Conformity for all products bearing the CE Marking.
- Prepare and submit 510(k) Premarket Notification, PMA, IDE, and Design Dossier submissions as directed.
- Ensure regulatory compliance to FDA and international regulations.
Technical Skills for Regulatory Affairs Specialist II:
- Knowledge and ability to review and approve ECO's and corporate SOP's.
- Sound knowledge and understanding of how IDE regulated clinical studies are performed.
- 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.
- Bachelor's degree in Science or Engineering (or related field) from an accredited college or university. A minimum of Five to Seven years direct experience in quality/regulatory affairs (preferably in the medical device/drug or biomedical
- 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.
- 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.
- 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.
- Sound knowledge and understanding of company products as they relate to medical device law and international medical devise requirements
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