Regulatory Affairs Specialist / Product Regulatory Engineer II

Omnicell • Pittsburgh, PA

230d

About The Position

Reporting to the Manager of Product Regulatory and located at the Omnicell Cranberry Woods, PA, Fort Worth, TX facility, or based remotely, the Quality and Regulatory Engineer will be responsible for supporting product regulatory activities.

Requirements

• Minimum (1) years quality/regulatory experience or relevant design/manufacturing engineering experience.
• Experience in product regulatory certifications.

Nice To Haves

• Minimum (5) years quality/regulatory experience.
• ISO 13485 or FDA regulated medical device experience.
• Experience working with complex electro-mechanical systems.
• Experience with global regulatory requirements for mechanical systems and testing such as UL, CSA or NTS.
• Bachelor's degree.

Responsibilities

• Maintain and track product safety certifications related to IEC 60601 and 61010 series of standards.
• Maintain the Applicable Standards Matrix.
• Track revisions to federal and global regulations to ensure timely compliance.
• 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.
• Escalate product compliance risks with objective findings and proposed resolutions.
• Support third party certification process for new products and product changes.
• Ensure compliance to internal QMS documentation and ISO 9001 or ISO 13485.
• Establish quality metrics to demonstrate the level of effectiveness of the regulatory process.
• Support the Quality Department objectives and goals by managing or participating in Quality projects.
• Manage and/or participate in CAPAs as required.

What This Job Offers

• Industry: Sporting Goods, Hobby, Musical Instrument, Book, and Miscellaneous Retailers
• Education Level: Bachelor's degree