Orange County Regulatory Affairs Discussion Group (OCRA)
Senior Regulatory Affairs Specialist
Orange County Regulatory Affairs Discussion Group (OCRA), Irvine, California, United States, 92713
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. Were looking for a
Senior Regulatory Affairs Specialist
to help bring our vision to life. In this role, youll be a key player in navigating the complex regulatory landscape, ensuring our groundbreaking products meet all compliance standards. Youll also contribute to our Quality Management System and play a vital role in our product teams. What Youll Do
As a Senior Regulatory Affairs Specialist, youll 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 Were Looking For
To thrive in this role, youll need: A
Bachelors 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, youll be contributing to a life-changing technology. Ready to Join the Team? If youre passionate about improving patient outcomes and have the skills to navigate the regulatory world, wed love to hear from you! Apply today and become part of Dialitys mission to redefine dialysis care. #J-18808-Ljbffr
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. Were looking for a
Senior Regulatory Affairs Specialist
to help bring our vision to life. In this role, youll be a key player in navigating the complex regulatory landscape, ensuring our groundbreaking products meet all compliance standards. Youll also contribute to our Quality Management System and play a vital role in our product teams. What Youll Do
As a Senior Regulatory Affairs Specialist, youll 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 Were Looking For
To thrive in this role, youll need: A
Bachelors 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, youll be contributing to a life-changing technology. Ready to Join the Team? If youre passionate about improving patient outcomes and have the skills to navigate the regulatory world, wed love to hear from you! Apply today and become part of Dialitys mission to redefine dialysis care. #J-18808-Ljbffr