Regulatory Affairs Analyst Exciting Growth Position International Medical

Description

Summary: Responsible for monitoring US FDA regulatory policy and guidance documents to support 510 K submission strategies. Examines, evaluates, and investigates eligibility for or conformity with laws and regulations governing FDA clearance and other applicable permits. Responsible for drafting and reviewing submission documents and interacting with other individuals within the Market Access Department as well as with regulatory bodies to facilitate timely and successful product clearances. Beyond the US, interactions could be with Canadian, European, and other international regulatory authorities.

Essential Duties and Responsibilities:

• Gather Regulatory Intelligence and provide regulatory strategies for products, including regulatory consultations, product characterization and safety assessments for well received and timely submissions.
• Work with the Market Access team to communicate submission and approval requirements early in the product lifecycle to assure that project plans are aligned with submission strategies and regulatory guidelines.
• Write and review regulatory documents with a critical eye for suitability for submissions to FDA and any other regulatory agencies as need be.
• Under the direction of the Director of Market Access, handle the preparation of electronic submission packages for regulatory agencies in compliance with applicable requirements & best practices.
• Identify issues early in the submission preparation process that could impact time lines/risks.
• Participate in multidisciplinary project teams within the Market Access Department providing guidance and direction on current regulatory pathways and expectations.
• Stay current on changes to the regulatory environment that could impact new product submission strategies.
• Monitor applications under review, manage and track submission and maintenance processes to support regulatory applications.
• Organize meetings within the Market Access Department with the goal of maintaining up to date knowledge of current and proposed regulatory documents.
• Review and document regulatory changes to commercialized devices. Maintain design control documentation and work with document control group to ensure regulatory document archiving is performed in an accurate and timely manner.
• Establishes and maintains business relationships with officials in federal and state government regulatory agencies.
• Performs other related duties as assigned.

Education and/or Experience:

• Bachelor’s Degree in a scientific or engineering discipline plus 3 to 5 years relevant experience in Regulatory Affairs in the area of In Vitro Diagnostics.
• Fluency in Microsoft Office applications (WORD, Powerpoint, EXCEL, Project) is required.
• Active participation in Regulatory industry associations is a plus.
• Strong critical thinking and analytical skills are required. Experience in the hands-on preparation of 510(k) submissions for In Vitro Diagnostic products required. Read, analyze, and interpret, and review scientific, technical and regulatory literature and documents. Prior facilitation of meetings with regulators will be considered as a valuable asset. Experience in working with regulatory consultants and contract research organizations is a plus. Prior Diagnostics experience is required.
• Fluency in French is a plus.
• Up to 30% Travel may be required depending on project demands, internationally as well as domestic.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.