Senior Regulatory Affairs Specialist

Orange County Regulatory Affairs Discussion Group (OCRA); Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Diality Inc. seeks a Senior Regulatory Affairs Specialist to navigate the regulatory landscape for innovative dialysis solutions. This role involves preparing submissions, maintaining licenses, and ensuring compliance, all while working in a collaborative and mission-driven environment focused on transforming patient care.

Benefits

Collaborative Environment

Growth Opportunities

Impactful Work

Qualifications

• At least 8 years of regulatory affairs experience in the medical device industry.
• Certification in Regulatory Affairs (RAC) is a plus.
• Proven US and EU regulatory submissions experience.

Responsibilities

• Prepare regulatory submissions (FDA, CE Marking).
• Provide regulatory guidance during product development.
• Collaborate on quality system projects and audits.

Skills

Communication

Organizational skills

Problem-solving

Collaboration

Education

Bachelor’s Degree

Job description

Position: Senior Regulatory Affairs Specialist

Location: Irvine, CA

Posted: January 6, 2025

Join Our Mission to Transform Dialysis Care!

Are you ready to make a difference in the lives of patients with kidney disease? Diality Inc., a privately held medical device company in Irvine, CA, is revolutionizing hemodialysis with a smart, portable, and flexible solution. Our innovative technology empowers patients to self-treat at home or anywhere they go, offering unparalleled versatility for dialysis in homes, nursing facilities, hospitals, and dialysis centers.

We’re looking for a Senior Regulatory Affairs Specialist to help bring our vision to life. In this role, you’ll be a key player in navigating the complex regulatory landscape, ensuring our groundbreaking products meet all compliance standards. You’ll also contribute to our Quality Management System and play a vital role in our product teams.

What You’ll Do

As a Senior Regulatory Affairs Specialist, you’ll have the opportunity to:

• Prepare and Coordinate Regulatory Submissions:
  • US FDA submissions (510(k), IDE, Pre-Submissions).
  • CE Marking under EU MDR.
  • Product amendments and renewals for various regulatory approvals.
• Obtain and Maintain Regulatory Licenses:
  • Oversee local, state, and national regulatory licensing and registration renewals.
  • Manage import/export permits.
• Provide Regulatory Guidance:
  • Ensure compliance with global regulatory requirements during product development and market launches.
  • Support marketed products, including labeling and promotional material reviews.
• Collaborate on Quality System Projects:
  • Support audits, inspections, and complaint handling.
  • Contribute to risk management and design assurance activities.
  • Assist in product recalls, corrections, and adverse event reporting.
• Drive Clinical and Commercial Success:
  • Lead post-market vigilance and follow-up activities.
  • Prepare FDA-Form 3500A for medical device reporting.
• Support Cross-Functional Teams:
  • Provide training and guidance to team members on regulatory processes.
  • Help shape templates and processes to improve efficiency.

What We’re Looking For

To thrive in this role, you’ll need:

• A Bachelor’s Degree and at least 8 years of regulatory affairs experience in the medical device industry.
• Certification in Regulatory Affairs (RAC) is a plus.
• Proven experience with US and EU regulatory submissions and direct interaction with the FDA.
• Expertise in ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations.
• Technical knowledge spanning Engineering, Operations, Quality, Marketing, and Clinical Research.
• Strong communication, organizational, and problem-solving skills.
• A proactive, “roll up your sleeves” attitude with a knack for collaboration.
• Start-up experience and familiarity with regulatory and clinical processes are a bonus!

Why Diality?

• Make an Impact: Work on a mission-driven product that will transform patient care.
• Collaborative Environment: Join a supportive team that values innovation and problem-solving.
• Growth Opportunities: Play a key role in a growing company and industry.
• Work with Purpose: Every day, you’ll be contributing to a life-changing technology.

Ready to Join the Team?
If you’re passionate about improving patient outcomes and have the skills to navigate the regulatory world, we’d love to hear from you! Apply today and become part of Diality’s mission to redefine dialysis care.