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Regulatory Affairs Specialist 2

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Job Type
Direct Hire
Jan 02, 2019
Job ID
Our mid-sized medical device client is building their regulatory department and launching over 20 new products into the market!  They have brought on new senior leadership and implementing a 3-year global quality and regulatory improvement program. This is a ground floor opportunity to write new submissions, remediation and new MDR work. The regulatory leadership team is creating a fun, possitive environment! The RA Specialist will 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.

Your role with the company:

  • 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.

  • Keep abreast of new and changing regulatory requirements.

  • Update RA procedures as needed to ensure company is in compliance with new and changing regulatory requirements.

  • Inform project teams of new and changing regulatory requirements.

  • This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).

  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

    Desired Profile:

  • 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 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.