Product Regulatory Specialist II (Quality Assurance Engineer II)

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

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.

 

Required Knowledge and Skills:

Ability to work collaboratively with peers and team members. Change agent who accepts and supports new ideas and processes. Strongly demonstrated written and verbal communication and presentation skills  Refined multi-tasking and time management skills. Ability to consistently balance sense of urgency with diplomacy/empathy. Strongly demonstrated attention to detail Commitment to cost reduction/controls. Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project) Ability to work under tight deadlines and handle multiple detail-oriented projects.

 

Basic Qualifications:

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

 

Preferred Qualifications:

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.

Work Conditions:

Office Environment May travel up to 10%