Role OverviewThe Quality Systems Compliance Specialist is responsible for proactively monitoring, analyzing, and communicating changes in the global regulatory and quality standards landscape relevant to the organization's products, processes, and markets. This role serves as the organization's primary resource for regulatory horizon-scanning, standards tracking, enforcement monitoring, and quality and compliance impact assessment.
What You Will Do
Monitor changes to FDA regulations, standards, and guidance documents; analyze new and proposed regulatory requirements and standards updates to assess their impact on the QMS, products, processes, and submissions; identify gaps between current QMS procedures and new or updated regulatory requirements and recommend remediation actions.
Why It Might Be a Fit
This is a forward-looking, analytically driven role that bridges quality systems management and regulatory strategy. The Quality Systems Compliance Specialist ensures the organization is always aware of and up-to-date on new or upcoming regulatory changes and that the organization's QMS is continuously positioned to meet and address those changes.
Requirements
- Bachelor's degree in sciences, compliance, regulatory affairs
- Minimum of 5 years of experience in Regulatory Affairs, Quality, engineering, or another regulated environment
- Strong working knowledge of global medical device regulations, guidance documents, and standards
- Demonstrated analytical and technical writing skills
- Excellent verbal communication and ability to clearly explain complex topics
- Strong project management capability and attention to detail
- Ability to work independently and manage multiple priorities
- Demonstrated ability to build cross-functional relationships and influence without authority
Benefits
- 401(k) employer match of 100% of each pretax dollar contributed on the first 4% and 50% of the next 2%
- benefits on day 1
- free onsite gym
- onsite cafeteria
- uncapped sales commissions
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