Website Berman Larson Kane
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|Market Access Regulatory Specialist|
The Market Access Regulatory Specialist will be responsible in managing the US regulatory submission strategies. He/She will be 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.
Provide regulatory strategies for products, including regulatory consultations, product characterization and safety assessments for well received and timely submissions.
Determine and 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 Operational Market Access Director, handle the preparation of submission packages for regulatory agencies in compliance with applicable requirements & best practices. Identify issues early in the submission preparation process that could impact timelines/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.
Work with document control group to ensure regulatory document archiving.
Bachelor’s Degree in a scientific or engineering discipline plus 6 or more years relevant experience in Regulatory Affairs in the area of In Vitro Diagnostics. Active participation in Regulatory industry associations is a plus.
Experience in the hands-on preparation of 510(k) submissions for In Vitro Diagnostic products required. Prior facilitation of face-to-face meetings with regulators will be considered as a valuable asset (e.g. PreSubmission meetings).
Experience in working with regulatory consultants and contract research organizations is a plus.
Prior Diagnostics experience is required.
Fluency in Microsoft Office applications (WORD, PowerPoint, EXCEL, Project) is required.
Strong organizational and project management skills are required.
Fluency in French is a plus.