Regulatory Affairs Specialist

• Develop regulatory strategies for product development and launch of moderate-complexity projects.
• Review and assess design and manufacturing changes for potential impact on current regulatory filings.
• Ensure compliance with design controls and review design documentation to confirm that it follows the regulatory requirements.
• Interpret existing regulations and guidance documents within regulatory department and on project teams.
• Provide regulatory expertise and oversight to design teams.
• Identify risk factors and contingency planning for assigned projects as related to regulatory decision making.
• Review product development to ensure 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.
• Interface as needed with FDA, Notified Bodies or other national health agencies 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 US.
• 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 labelling (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.
• Bring Regulatory Affairs questions/issues to the attention of RA management.
• Prepares update reports for RA management.
• Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
• Perform other duties as assigned or necessitated by business conditions or changes.

• A bachelor's degree in a science or engineering field is preferred.
• Minimum of 2 to 4 years of experience working in medical device regulatory affairs (or equivalent regulated industry).
• Experience in the skillful preparation of regulatory submission dossiers for class I or II medical devices is highly preferred.

• Advanced English 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.

Teleflex