Regulatory Affairs Specialist

Regulatory Affairs Specialist (Medical Device)

Zing Recruiting, in partnership with an established medical equipment manufacturer stationed in Parsippany, New Jersey is on the search for an experienced Regulatory Affairs Specialist to join their team. This is a fully on-site opening. The candidate in this role must have strong experience within In Vitro Diagnostics.

Salary: $80,000-100,000K, Based on Experience Level

Location: Parsippany, NJ

Regulatory Affairs Specialist Responsibilities

• 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.
• 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.
• 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.
• Write and review regulatory documents with a critical eye for suitability for submissions to FDA and any other regulatory agencies as need be.
• Participates and/or leads key negotiations and interactions with regulatory authorities during all stages of the development and review process.
  
  

Regulatory Affairs Specialist Requirements

• Bachelor's Degree in a scientific or engineering discipline plus 5 or more years relevant experience in the area of In Vitro Diagnostics. Applicants with educational backgrounds in Regulatory Affairs or related Health Care Management Degrees are preferred.
• Active participation in regulatory industry associations is a plus; RAC preferred.
• 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.
• 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.
  
  

Qualified candidates will be contacted immediately!

Zing Recruiting's dedication to the safety, health & well-being of our associates, clients and communities remains our #1 priority. Zing Recruiting is proud to be an EEOE, M/F/D/V, and we are committed to diversity both in practice and spirit at all levels of the organization.

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