Keely DeWit

IDR is seeking a Regulatory Affairs Specialist to join one of our top clients in a remote capacity. This role is pivotal in ensuring product safety and compliance with regulatory standards for medical devices. If you are looking for an opportunity to join a growing organization and work within an ever-growing team-oriented culture, please apply today!

Position Overview/Responsibilities for the Regulatory Affairs Specialist:

• Identify, assess, and communicate product safety risks, developing action plans to address them effectively.

• Ensure compliance with global medical device reporting and complaint management standards, collaborating with European Headquarters and other stakeholders.

• Provide expert guidance to regulatory agencies and participate in investigations of potentially reportable events, analyzing data and documentation.

• Track and report on all stages of the investigation process, including data analysis, documentation review, and complaint coordination.

• Assist with investigations, including failure analysis and corrective actions, working closely with Engineering, Manufacturing, and Quality Assurance teams.

Required Skills for Regulatory Affairs Specialist:

• 3-5 years of experience in a highly regulated environment, preferably in the medical device or pharmaceutical industries.

• Experience in Quality, Product Safety, Product Surveillance, or Vigilance is preferred.

• Strong customer and service orientation with a conscientious, reliable, and independent work style.

• Excellent communication and conflict resolution skills, with a high sense of personal accountability.

• A 4-year degree or equivalent experience is required, with commercial or medical training preferred.

What's in it for you?

Competitive compensation package

Full Benefits; Medical, Vision, Dental, and more!Opportunity to get in with an industry-leading organizationClose-knit and team-oriented culture

Why IDR?

25+ Years of Proven Industry Experience in 4 major markets

Employee Stock Ownership ProgramMedical, Dental, Vision, and Life InsuranceClearlyRated's Best of Staffing® Client and Talent Award winner 12 years in a row

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