Regulatory Affairs Specialist, Selution

4 weeks ago

Irvine, United States Cordis Full time

Overview:
MedAlliance is a leading and innovative combination medical device company dedicated to improving patient outcomes and enhancing healthcare worldwide. We specialize in the development, manufacturing, and commercialization of cutting-edge coronary and peripheral medical devices that integrate pharmaceuticals with traditional medical devices. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet medical needs.

The primary responsibility of the position is to support regulatory strategy and registration across global markets for a defined group of MedAlliance/Cordis products, drive regulatory processes and activities (such as change control review of labelling, review of marketing materials, etc) and continue to develop strong working relationships with internal and external customers.

**Responsibilities**:

- The Regulatory Affairs Specialist (RAS) is responsible for the management of global and regional regulatory projects, including, but not limited to, the regulatory aspects of new product development, product life-cycle management, and changes to existing products.
- Preparation and authorship of regulatory submissions such as EU Technical Documentation and US FDA IDE/PMA submissions, including interfacing with regulatory authorities as needed
- Advise core teams on strategies and registration requirements for product development, investigational devices, and commercialized products.
- Lead regulatory assessment and actions for changes to product and QMS processes.
- Coach and educate team members on regulatory principles and policies throughout the organization via training and mentorship.
- Review, interpret and communicate EU/international regulations and guidance documents to ensure complete and scientifically sound product submissions.
- Support base business activities, such as Registration renewals, Annual Reports, Supplements, Labeling reviews, UDI/EUDAMED
- Own and drive continuous improvement of internal regulatory policies and procedures, and maintenance of existing procedures.
- Supports regulatory compliance to QSR, ISO, MDSAP, CE and other worldwide regulatory requirements as appropriate through customer complaints, internal and external audits, and training systems.
- Provide guidance to business partners while aligning and coordinating regulatory strategy and deliverables with more senior regulatory staff members.

Qualifications:

- Bachelor in Science/Biomedical/Pharmacy or equivalent professional experience.
- 2+ years of experience in regulatory affairs in medical device/pharmaceutical industry, GLP, ISO 13485 environment
- Experience in FDA / EU regulations for class III medical device
- Analytical and Critical Thinker
- Always Learning Mentality
- Concise and clear writing on technical topics

Pay / Compensation

The expected pre-tax pay rate for this position is $80,400 - $108,000

Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

Why Join Cordis?

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.

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