Principal Specialist Regulatory Affairs, Selution (Irvine, CA or Remote)
US-AnywhereRemote in Irvine, CA
More than 3 months ago
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Job Description
Overview
MedAlliance, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).
If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then this is the place for you. Join us, and let's improve the wellbeing of millions, together.
We are the people behind the people who keep saving lives.
**Prefer someone in Irvine, CA but open to remote.**
MedAlliance (Cordis) are seeking a highly skilled and motivated Principal Regulatory Affairs Specialist to join our dynamic team. This role will play a crucial part in preparing and submitting PMA modules for a Class III combination product. The ideal candidate will possess strong clinical experience and a proven track record in regulatory affairs within the medical device industry.
Responsibilities
Valuable Expertise:
Qualifications
Pay / Compensation
The expected pre-tax pay rate for this position is $89,500 - $130,000
Actual pay may fluctuate outside of the range depending on skills, education, experience, job-related knowledge and location.
Benefits: Med Alliance offers a competitive benefits package including:
MedAlliance, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).
If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then this is the place for you. Join us, and let's improve the wellbeing of millions, together.
We are the people behind the people who keep saving lives.
**Prefer someone in Irvine, CA but open to remote.**
MedAlliance (Cordis) are seeking a highly skilled and motivated Principal Regulatory Affairs Specialist to join our dynamic team. This role will play a crucial part in preparing and submitting PMA modules for a Class III combination product. The ideal candidate will possess strong clinical experience and a proven track record in regulatory affairs within the medical device industry.
Responsibilities
- Lead regulatory strategy development and execution for PMA submissions, ensuring compliance with FDA regulations and guidance.
- Collaborate cross-functionally with R&D, Quality Assurance, and Clinical teams to support the development of combination products and medical devices.
- Prepare and submit regulatory documents, including PMA applications, with emphasis on clinical module.
- Directs and supports interactions with regulatory agencies and providing timely responses to inquiries.
- Stay current on industry trends, regulatory changes, and best practices to inform company strategy and ensure compliance.
- Provide training and guidance to junior regulatory staff on regulatory requirements and processes.
- Develop and maintain regulatory affairs policies and procedures to enhance operational efficiency.
- Help manage FDA IDE/PMA clinical reports/modules and post approval clinical study activities and be involved in clinical evaluation processes.
- Interpret clinical evidence in the context of applicable regulations, standards, and guidelines (e.g., FDA guidance, MEDDEV 2.7/1, MDR,).
- Support literature reviews and research to stay abreast of industry trends, competitor products, and emerging technologies.
Valuable Expertise:
- In-depth knowledge and understanding of FDA submissions for IDE and PMA process
- Previous experience with authoring clinical modules for FDA submissions
- Knowledge and understanding of clinical evaluation documentation to MEDDEV 2.7/1 guidelines
- Previous experience in medical writing, preferably within the device-drug combination devices
- Previous experience in Post Market Surveillance activities (PMS) and Post Market Clinical Follow-up activities (PMCF)
- Expert knowledge of regulatory requirements and guidance documents for medical devices with FDA regulations (e.g., IDE, PMA) and familiarity with international standards (e.g., ISO 13485, EU MDR, MEDDEV 2.7/1, ISO14155, MDCG).
Qualifications
- Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
- 8-10 years of experience in regulatory affairs within the medical device industry, with a strong focus on PMA submissions.
- Experience with combination products is highly desirable.
- Experience in clinical research is highly desirable.
- In-depth knowledge of FDA regulations and guidance pertaining to medical devices and combination products.
- Excellent communication, negotiation, and interpersonal skills.
- Strong analytical and problem-solving abilities, with a proactive approach to regulatory challenges.
- Ability to work independently and as part of a team in a fast-paced environment.
Pay / Compensation
The expected pre-tax pay rate for this position is $89,500 - $130,000
Actual pay may fluctuate outside of the range depending on skills, education, experience, job-related knowledge and location.
Benefits: Med Alliance offers a competitive benefits package including:
- 401(k)
- Medical, Dental and Vision Insurance
- Life insurance
- Paid time off
About Cordis
Learn More About CordisCordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis the world's leading developer and manufacturer of breakthrough stents, catheters and guidewires for interventional medicine, minimally invasive computer-based imaging, and electrophysiology.
Joining Cardinal Health means becoming part of a team committed to pushing the boundaries of healthcare innovation and leadership. As a global leader in healthcare services and products, we offer unparalleled job opportunities designed to empower your career growth.
Work You’ll Do
At Cardinal Health, we are dedicated to creating an environment where professionals can thrive through diverse training and robust career development. We believe in fostering a culture that values diversity and drives innovation.
Lead in a Dynamic Field
Take a leading role in the healthcare industry with Cardinal Health. Our team is at the forefront of developing solutions that improve patient care and reduce costs. With positions ranging from logistics and operations to advanced analytics and pharmaceutical development, your work will directly impact lives around the world.
Join Our Inclusive Team
Be part of a culture that celebrates diversity and is committed to creating an inclusive environment for all employees. At Cardinal Health, we understand that unique perspectives lead to innovative ideas and better decision-making.
Innovate with Us
Our commitment to innovation is fundamental. Cardinal Health is a place where you can work with cutting-edge technology and collaborate with industry experts to deliver solutions that make healthcare safer and more effective.
Grow Your Career
Cardinal Health supports your professional growth with comprehensive benefits, continuous learning opportunities, and a clear path to advancement. From leadership programs to internships, we provide the tools to build your skills and advance your career.
Explore Job Opportunities
Whether you’re looking for an internship, a full-time position, or a leadership role, Cardinal Health offers a range of employment options to help you meet your career goals. Our hiring process is designed to match your skills and interests with the right opportunities within our company.
Stay Connected
Join Our Team
Search for open positions that align with your skills and interests. We are always looking for passionate, curious, and solution-driven team players.
Keep Up to Date
Stay informed with career tips, insider perspectives, and industry-leading insights—all from the people who work here.
Networking and Professional Development
Enhance your career with our networking events, professional development sessions, and comprehensive benefits designed to boost your career journey.
Job Alert Emails
Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Cardinal Health.
Join Cardinal Health today and be part of a team that’s dedicated to improving the future of healthcare. Explore our careers page to find out how you can contribute to our mission and advance your professional journey.
Cardinal Health Careers
Joining Cardinal Health means becoming part of a team committed to pushing the boundaries of healthcare innovation and leadership. As a global leader in healthcare services and products, we offer unparalleled job opportunities designed to empower your career growth.
Work You’ll Do
At Cardinal Health, we are dedicated to creating an environment where professionals can thrive through diverse training and robust career development. We believe in fostering a culture that values diversity and drives innovation.
Lead in a Dynamic Field
Take a leading role in the healthcare industry with Cardinal Health. Our team is at the forefront of developing solutions that improve patient care and reduce costs. With positions ranging from logistics and operations to advanced analytics and pharmaceutical development, your work will directly impact lives around the world.
Join Our Inclusive Team
Be part of a culture that celebrates diversity and is committed to creating an inclusive environment for all employees. At Cardinal Health, we understand that unique perspectives lead to innovative ideas and better decision-making.
Innovate with Us
Our commitment to innovation is fundamental. Cardinal Health is a place where you can work with cutting-edge technology and collaborate with industry experts to deliver solutions that make healthcare safer and more effective.
Grow Your Career
Cardinal Health supports your professional growth with comprehensive benefits, continuous learning opportunities, and a clear path to advancement. From leadership programs to internships, we provide the tools to build your skills and advance your career.
Explore Job Opportunities
Whether you’re looking for an internship, a full-time position, or a leadership role, Cardinal Health offers a range of employment options to help you meet your career goals. Our hiring process is designed to match your skills and interests with the right opportunities within our company.
Stay Connected
Join Our Team
Search for open positions that align with your skills and interests. We are always looking for passionate, curious, and solution-driven team players.
Keep Up to Date
Stay informed with career tips, insider perspectives, and industry-leading insights—all from the people who work here.
Networking and Professional Development
Enhance your career with our networking events, professional development sessions, and comprehensive benefits designed to boost your career journey.
Job Alert Emails
Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Cardinal Health.
Join Cardinal Health today and be part of a team that’s dedicated to improving the future of healthcare. Explore our careers page to find out how you can contribute to our mission and advance your professional journey.
