Overview
When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.
Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.
At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.
If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives.
Position
MedAlliance (Cordis) are seeking a highly skilled and motivated Senior Regulatory Affairs Specialist to join our dynamic team. This role will play a crucial part in preparing and compiling regulatory documents for a Class III combination product. The ideal candidate will possess extensive experience in global regulatory submissions, in particular in the US and EU, and a proven track record in regulatory affairs within the medical device industry.
Responsibilities
1. Collaborate cross-functionally with R&D, Quality Assurance, and Clinical teams to support the development of combination products and medical devices.
2. Prepare and submit regulatory documents, including PMA applications, with emphasis on clinical writing.
3. Direct and support interactions with regulatory agencies and provide timely responses to inquiries.
4. Stay current on industry trends, regulatory changes, and best practices to inform company strategy and ensure compliance.
5. Develop and maintain regulatory affairs policies and procedures to enhance operational efficiency.
6. Help manage FDA IDE/PMA clinical reports/modules and post-approval clinical study activities and be involved in clinical evaluation processes.
7. Interpret clinical evidence in the context of applicable regulations, standards, and guidelines (e.g., FDA guidance, MEDDEV 2.7/1, MDR).
8. Support literature reviews and research to stay abreast of industry trends, competitor products, and emerging technologies.
Valuable Expertise:
1. Good knowledge and understanding of FDA submissions for IDE and PMA process.
2. Previous experience with authoring clinical submissions for global regulatory agencies, in particular FDA and Notified Body.
3. Knowledge and understanding of clinical evaluation documentation to MEDDEV 2.7/1 guidelines.
4. Previous experience in medical writing, preferably within the device-drug combination devices.
5. Previous experience in Post Market Surveillance activities (PMS) and Post Market Clinical Follow-up activities (PMCF).
6. 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
1. Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
2. 5 - 7 years of experience in regulatory affairs within the medical device industry, with a strong focus on clinical writing.
3. Experience with combination products is highly desirable.
4. Experience in clinical research is highly desirable.
5. In-depth knowledge of FDA regulations and guidance pertaining to medical devices and combination products.
6. Excellent communication, negotiation, and interpersonal skills.
7. Strong analytical and problem-solving abilities, with a proactive approach to regulatory challenges.
8. 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 $91,850 - $123,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge, and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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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