Regulatory Affairs Specialist

Job Title:Senior Regulatory Affairs Specialist
Location:Santa Clara, CA (Onsite)
Pay Range: 60

What's the Job?

• Support multiple business units by developing, updating, and improving Regulatory Affairs processes and procedures.
• Assist regulatory strategy implementation and operations, including product registration submissions, progress reports, supplements, amendments, and periodic reports.
• Develop and maintain regulatory procedures to support changes in the regulatory landscape, including EU MDR requirements.
• Support regulatory changes by identifying process improvement opportunities and driving them through completion.
• Collaborate cross-functionally and in a matrixed environment to ensure regulatory activities align with product development needs.

What's Needed?

• Strong Regulatory Affairs experience within the Medical Device industry, including hands-on FDA submissions for new products.
• Working knowledge of both US and EU medical device regulations, including EU MDR.
• Direct experience preparing and managing regulatory submissions, including regulatory documentation and reporting.
• Ability to assess regulatory impact of product or document changes and determine submission requirements resulting from modifications.
• Experience supporting internal and external inspections and working effectively with teams during regulatory readiness activities.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!