Regulatory Affairs Submission Specialist

The Regulatory Affairs Specialist is responsible for working with product development and manufacturing management to ensure that the product development process meets all applicable regulatory requirements. Participate as a member of project teams. Responsible for the approval of labeling, marketing literature and finished good specifications. 

Must have 510k / IDE submissions experience.

• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Utilize this understanding to develop clear procedures for the organization.
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Act as a liaison between their organization and state, local, federal, and international agencies. Including communicate on pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Participate as a member of project teams to ensure Design Control, Risk Management, and Release to Market activities are in compliance with appropriate standards/regulations
• Coordinate, prepare and review documentation for international and domestic submissions for to FDA, Health Canada and other international regulatory agencies.
• Strategically achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, technology, compliance, and costs.
• Responsible for advising project teams on various subjects, including export and labeling requirements, premarket regulatory requirements, and clinical study compliance issues.
• Provide documentation in response to outside inquires relating to Good
• Tissue Practices/Good Manufacturing Practices.
• Participate in internal or external audits.
• Review and approve MTF labeling, and finished good specifications. As well as the Marketing Literature of our business partners.
• Create, review and update Design History Files (DHFs) and Device Master Records (DMRs) as well as conduct periodic audits of the files and documents to ensure compliance with MTF Design Control procedures.
• Provide technical support during product recalls
• Assist on special projects and perform additional duties as assigned

• Bachelor's degree in science or a related field

• 5 years’ experience with FDA (510k / IDE) submissions

• Knowledge of GTPs/GMPs
• Ability to work on project teams.
• Strong communication, organizational and time management skills. Technical writing skills.
• Proficient in Microsoft Office

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