Product Regulatory Engineer II
| Company | Omnicell |
|---|---|
| Location | Pittsburgh, PA, USA, Fort Worth, TX, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | |
| Experience Level | Mid Level, Senior |
Requirements
- 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.
- Minimum (1) years quality/regulatory experience or relevant design/manufacturing engineering experience
- Experience in product regulatory certifications
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.
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.