Regulatory Affairs Staff Specialist - Diagnostica Stago : Job Details

Summary: Ensures compliance with regulations and guidelines set by the US FDA. Specifically for Hemostasis IVD tests and laboratory instrumentation, which are used for patient clinical evaluations. Ensures that the Hemostasis instrumentation and diagnostic tests meet all applicable FDA regulations and guidelines. This includes preparing and submitting regulatory submissions, such as 510(k) premarket clearances, De Novo Classifications and Premarket Approval (PMA) applications, and ensuring they contain accurate and complete information. Contributes to the development of regulatory strategies for bringing devices to market or making changes to existing devices. This involves staying updated on FDA regulations, guidelines, and industry standards, and providing guidance to the development and manufacturing teams.

Essential Duties and Responsibilities:

* Responsible for the review, maintenance and monitoring of documentation related to the device's regulatory compliance, such as technical files, design dossiers, and labeling requirements. The specialist acts as a liaison between the Market Access Team and the FDA. They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access.

* Identifies regulatory pathways for initial product designs and provides input to internal stakeholders in preparation of FDA 510 K and De Novo submissions using a risk-based approach.

* Analyzes and communicate the adequacy of proposed regulatory pathways and strategy for initial product designs and recommend changes or refinements based on initial regulatory outcomes.

* 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 US Market Access, handles the preparation of electronic submission packages for regulatory agencies in compliance with applicable requirements & best practices.

* Evaluate regulatory policy and critically assesses the impact of changing regulations on pre-approval and post-approval strategies and approaches and advises internal stakeholders on a course of action.

* Participate in multidisciplinary project teams within the US 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.

* Work closely with quality assurance and quality control teams to establish and maintain appropriate quality systems for IVDs. This includes ensuring compliance with Good Manufacturing Practices (GMP) and Quality System Regulations (QSR).

* Establishes working relationships and interfaces and with multiple government and non-government organizations having an impact on market access and distribution.

* Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures (SOPs).

* Frames issues with a thorough understanding of legislation, regulations, guidance, policy and directives.

* Creates work plans with appropriate staging of activities and with clearly defined milestones.

* Remains up-to-date on scientific and clinical advances that impact healthcare product development and assesses the relationship to regulation and regulatory issues.

* Provides strategic input and technical guidance on global regulatory requirements to product development teams.

* Work with document control group to ensure regulatory document archiving.

* Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.

* Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions.

* Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans.

* Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.

* Participates and/or leads key negotiations and interactions with regulatory authorities during all stages of the development and review process.

* 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 5 or more 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; RAC preferred.

* Strong critical thinking and analytical skills are required. Good understanding of the IVD marketplace and have ability to analyze the impact of new regulations, interpret policies in clear terms, and identify the best ways to comply with regulations using a risk-based approach experience in the hands-on preparation of 510(k) submissions for In Vitro Diagnostic products required. 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. Excellent analytical and writing skills. Excellent interpersonal, written and oral communication skills. Prior Diagnostics experience is required.

* Fluency in French is a plus.

* Up to 30% Travel (International and Domestic) may be required depending on project demands.

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.