Product Regulatory Compliance Specialist

6 days ago


Pittsburgh, Pennsylvania, United States Omnicell Full time
Job Description

We are seeking a Product Regulatory Compliance Specialist to join our team. This role will be responsible for supporting product regulatory activities.

The ideal candidate will have experience in product regulatory certifications and a strong understanding of IEC 60601 and 61010 series of standards. They will also have excellent written and verbal communication skills, with the ability to work collaboratively with peers and team members.

The successful candidate will have a minimum of one year's quality/regulatory experience or relevant design/manufacturing engineering experience. A bachelor's degree is preferred, but not required.

As a Product Regulatory Compliance Specialist, you will be responsible for maintaining and tracking product safety certifications, identifying and maintaining product regulatory requirements, and providing input on quality/regulatory product requirements for new product development projects.

Key Responsibilities:

  • Maintain and track product safety certifications related to IEC 60601 and 61010 series of standards.
  • Identify and maintain product regulatory requirements for domestic and international products.
  • Work with global third-party distributors to maintain product regulatory compliance.
  • Provide input on Quality/Regulatory Product Requirements for new product development projects.
  • Develop standard global processes to support product regulatory compliance activities.

Benefits:

  • Competitive salary: $95,000 - $115,000 per annum, based on location and experience.
  • Opportunities for professional growth and development.
  • A dynamic and inclusive work environment.

About Omnicell

Omnicell is a leading provider of pharmacy automation solutions. We strive to be the healthcare provider's most trusted partner by our guiding promise of 'Outcomes. Defined and Delivered.'

Our comprehensive portfolio of robotics, smart devices, intelligent software, and expert services is helping healthcare facilities worldwide to improve business and clinical outcomes as they move closer to the industry vision of the Autonomous Pharmacy.



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