17 days old

Senior FDA Regulatory Specialist

Honeywell
Smithfield, RI 02917

Join a team recognized for leadership, innovation and diversity

The future is what you make it.

When you join Honeywell, you become a member of our global team of thinkers, innovators, dreamers and doers who make the things that make the future.

That means changing the way we fly, fueling jets in an eco-friendly way, keeping buildings smart and safe and even making it possible to breathe on Mars.

Working at Honeywell isn€™t just about developing cool things. That€™s why all of our employees enjoy access to dynamic career opportunities across different fields and industries.

Are you ready to help us make the future?

Be a part of a team of global Regulatory Compliance Engineers that applies its expertise and knowledge in finding innovative, cost-effective means to improve quality output and continuous improvements. The Food & Drug Administration (FDA) and Personal Protective Equipment (PPE) Regulatory Compliance Engineer will have responsibility for the regulatory submissions, regulatory compliance, regulatory advice and counseling for all relevant product registrations.  An integral part of this role is to build a relationship with the FDA, Notified Bodies and international regulatory authorities.

RESPONSIBILITIES

·         Product compliance applications and certification, site certification renewals and site audits to regulatory standards

·         Acts as business focal for all PPE and Food, Drug, and Device related meetings communications and subject matter expertise committees

·         Own the process of chosen sites becoming ISO 13485 compliant

·         Knowledge of the FDA Unique Device Identification requirement

·         Identify and support new FDA and PPE regulatory standard changes to products

·         Drive required FDA general support for registration, certification; audit of cGMP of PPE manufacturers.

·         Support PPE NPI and sustaining projects as assigned

·         Ensure supplier cGMP€™s practices are maintained at selected sites via site audit

·         Solve problems where situational analysis is required to meet customer requirements

·         Uses problem analysis to proactively identify quality process solutions

·         Provide analysis of data in support of quality and process improvements

YOU MUST HAVE

  • Bachelor€™s Degree
  • Two 2+ years€™ hands-on experience working with FDA cGMP and ISO 13485 standards and processes

    WE VALUE

    • Experience with FDA submissions including 510k 
    • Experience working with the FDA and PPE regulatory administration and product compliance
    • Ability to develop and monitor a quality system, including the ability to write policies and procedures.
    • Experience in creating and implementing a document control system.

      ·         Possess strong oral and written communication skills with proven ability to generate regulatory and or governmental submissions.

      ·         Strong knowledge of FDA requirements relating to regulatory submissions and clinical investigations.

      ·         Well versed in usage of MS Office products e.g. Xcel, PowerPoint.

      ·         Capable of managing multiple projects at once with various deliverables.

      ·         Strong oral and written communication skills

       

      Additional Information
      • JOB ID: HRD94569
      • Category: Integrated Supply Chain
      • Location: 10 Thurber Blvd,Smithfield,Rhode Island,02917,United States
      • Exempt