Job Description

• Perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.
• Supports necessary regulatory activities required for product market entry of instrument hardware and software.
• Conduct reviews of product and manufacturing changes of instrument hardware and software for compliance with applicable regulations.
• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.
• Provides guidance and expertise.
• Review and evaluate communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission database and file systems.
• Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• May interface directly with FDA and other regulatory agencies.
• Work with a cross-functional team to support the product release process.
• Review protocols and reports to support regulatory submissions.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• Bachelor's Degree in life sciences or engineering, or other technical discipline.
• 6 years of Regulatory affairs job experience in the medical device industry.
• Technical or Medical Writing experience.
• Must be familiar with relevant US/international regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
• Proficient with MS Office Suite (Word, Excel, PowerPoint, Outlook).
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Experience with pre-submissions, 510k submissions, Instrument/Software Submission experience, Design Planning, and On-Market Changes.

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