Senior Regulatory Specialist

Location: Santa Clara, CA

Contract Length: 12 Months

Pay Rate: $47–48/hr

Now Hiring: Senior Regulatory Affairs Specialist

We are partnering with a leading medical device company on a Senior Regulatory Affairs Specialist opportunity in Santa Clara, CA.

This role will focus on global regulatory operations and international tender support, serving as a key liaison across Regulatory Affairs, Quality, Manufacturing, Supply Chain, Legal, and international affiliates.

Key responsibilities include:

• Leading end-to-end regulatory support for global tenders and international markets

• Managing regulatory documentation including CFGs, COEs, Letters of Authorization, Powers of Attorney, and Declarations of Conformity

• Supporting EU MDR compliance activities and document translations

• Driving cross-functional initiatives and ensuring timely execution of regulatory deliverables

• Developing trackers, dashboards, and process improvements to support operational excellence

Ideal candidates will have:

• Regulatory Affairs or Regulatory Operations experience within medical devices, diagnostics, biotech, or pharmaceutical environments

• Experience supporting global regulatory requirements and international markets

• Knowledge of EU MDR, DoCs, CFGs, COEs, LoAs, and PoAs

• Strong project management and stakeholder management skills