Regulatory Affairs Specialist

1 day ago

Parsippany, New Jersey, United States Diagnostica Stago Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Staff Specialist to join our team at Diagnostica Stago. The successful candidate will be responsible for ensuring compliance with regulations and guidelines set by the US FDA, specifically for Hemostasis IVD tests and laboratory instrumentation.

Key Responsibilities
  • Prepare and submit regulatory submissions, such as 510(k) premarket clearances, De Novo Classifications, and Premarket Approval (PMA) applications, ensuring they contain accurate and complete information.
  • Contribute to the development of regulatory strategies for bringing devices to market or making changes to existing devices.
  • Stay updated on FDA regulations, guidelines, and industry standards, and provide guidance to the development and manufacturing teams.
  • Review, maintain, and monitor documentation related to the device's regulatory compliance, such as technical files, design dossiers, and labeling requirements.
  • Act as a liaison between the Market Access Team and the FDA, engaging in correspondence, meetings, and interactions to address regulatory inquiries and respond to requests for additional information.
  • Identify regulatory pathways for initial product designs and provide input to internal stakeholders in preparation of FDA 510 K and De Novo submissions using a risk-based approach.
  • Analyze 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 other regulatory agencies.
  • Under the direction of the Director of US Market Access, analyze and interpret clinical trial data with a thorough understanding of the product's design, intended indications for use, and required performance characteristics.
  • Prepare electronic submission packages for regulatory agencies in compliance with applicable requirements and best practices.
  • Evaluate regulatory policy and critically assess the impact of changing regulations on pre-approval and post-approval strategies and approaches.
  • 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, ensuring compliance with Good Manufacturing Practices (GMP) and Quality System Regulations (QSR).
  • Establish working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.
  • Identify the need for and manage the development and execution of new regulatory procedures and standard operating procedures (SOPs).
  • Frame issues with a thorough understanding of legislation, regulations, guidance, policy, and directives.
  • Create work plans with appropriate staging of activities and clearly defined milestones.
  • Remain up-to-date on scientific and clinical advances that impact healthcare product development and assess their relationship to regulation and regulatory issues.
  • Provide strategic input and technical guidance on global regulatory requirements to product development teams.
  • Work with document control group to ensure regulatory document archiving.
  • Evaluate risks of product and clinical safety issues during clinical phases and recommend regulatory solutions.
  • Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans for changes that do not require submissions.
  • Review and assess non-clinical and clinical trial protocols to ensure compliance with globally accepted regulatory guidelines and standards.
  • Ensure clinical and nonclinical data are consistent with regulatory requirements and support proposed product claims.
  • Participate in and/or lead key negotiations and interactions with regulatory authorities during all stages of the development and review process.
  • Establish and maintain business relationships with officials in federal and state government regulatory agencies.
Requirements
  • Bachelor's Degree in a scientific or engineering discipline plus 5 or more years of relevant experience in the area of In Vitro Diagnostics.
  • Applicants with educational backgrounds in Regulatory Affairs or related Health Care Management Degrees are preferred.
  • Fluency in Microsoft Office applications (WORD, PowerPoint, EXCEL, Project) is required.
  • Strong organizational and project management skills are 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 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

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