The Regulatory Affairs Specialist will develop strategies and submissions for the companys products. Submissions will be globally based for our products. Submissions will be at moderate to complex level, and relate to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The incumbent is also responsible for staying abreast of evolving global regulatory requirements.

• Develop regulatory strategies for product development and launch of moderate-complexity projects.
• Review and assess of change control activities for potential impact on current regulatory filings.
• Ensures compliance with design controls and reviews design documentation to ensure that it follows the regulatory requirements.
• Interpret existing regulations and guidance documents within regulatory department and on project teams.
• Provides a regulatory expertise and oversight to design teams.
• Identify risk factors and contingency planning for assigned projects.
• Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance.
• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks.
• Interfaces as needed with FDA, Notified Bodies or other national health agency regarding new products and significant changes to products.
• Assume full responsibility for project submissions, from guidance/strategies/authoring/obtaining approvals, including 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required for registration/licensure of products outside the U.S.
• Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information.
• Review and approve all labeling (product, advertising and promotional) verbiage.
• Understand and communicate regulatory processes, guidelines and guidance documents and what they mean to the organization.
• Apply understanding of the quality systems to job activities and projects.
• Participate in training RA team members and others on compliance matters.
• Brings Regulatory Affairs questions/issues to the attention of RA management.
• Prepares monthly reports to RA management.
• Adhere to and ensure the compliance of the companys Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
• Other duties as assigned.

• A bachelors degree in a science or engineering field is preferred.
• 2-3 years of regulatory affairs experience in a regulated environment is required.
• Regulatory affairs experience in domestic and international submissions, with 2-3 years of overall class I or II medical devices is highly preferred.

• Strong communication skills (verbal and technical writing)
• Strong attention to detail
• Strong analytical and critical thinking skills
• Ability to organize, prioritize, manage multiple projects and meet deadlines
• Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality
• Knowledge of electronic document management systems
• Ability to apply Business and Regulatory Affairs ethical standards
• Proficiency in MS Word, Excel, Power Point, and Outlook