Job Description

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.

• 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).

• 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

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