Regulatory Affairs Specialist

Website Berman Larson Kane

Best Medical Manufacturing Staffing since 1980

Description Summary: The Regulatory Affairs Staff Specialist is responsible for defining US regulatory submission strategies, drafting and reviewing submission documents, and interacting with other individuals within the US Market Access department, development counterparts, as well as with regulatory bodies to facilitate timely and successful product clearances.

Essential Duties & Responsibilities:

  • Identifies regulatory pathways for initial product designs and provides input to internal stakeholders.
  • Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes o 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 submission packages for regulatory agencies in compliance with applicable requirements & best practices
  • Critically assesses the impact of changing regulations on preapproval 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.
  • Monitor applications under review, manage and track submission and maintenance processes to support regulatory applications.
  • 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.

Education & Requirements:

  • 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.
  • Active participation in regulatory industry associations is a plus.
  • RAC registration preferred.
  • Prior Diagnostics experience is required.
  • Up to 30% Travel (International and Domestic) may be required depending on project demands.

Skills:

  • Fluency in Microsoft Office applications (WORD, PowerPoint, EXCEL, Project) is required. Strong organizational and project management skills are required.
  • 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. Pre-Submission meetings, submission issue meetings, etc.).
  • 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.
  • Fluency in French is a plus.

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