Job Information
Cordis Technical Writer - Regulatory Affairs, Selution (Irvine, CA or Hybrid) in Irvine, California
Overview
Cordis is a pioneering medical technology company specializing in groundbreaking solutions for cardiovascular and peripheral vascular diseases. 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.
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.
MedAlliance (Cordis) are currently seeking a Technical Writer to join our Regulatory Affairs department, focusing on the development of high-quality documentation, including Instructions for Use (IFUs), to support our product compliance and regulatory submissions. As a Technical Writer within the Regulatory Affairs department, you will play a crucial role in creating and maintaining documentation that meets regulatory standards. You will collaborate with various teams, including engineering, quality assurance, clinical and regulatory specialists, to ensure that all documentation accurately reflects product information and adheres to industry regulations.
Responsibilities
Develop IFUs: Write, edit, and maintain clear and compliant IFUs and other regulatory documents for medical devices.
Package Label: Develop content for package labeling.
Collaboration: Partner with cross-functional teams to gather necessary technical information and ensure accurate representation of product functionalities and safety features.
Regulatory Compliance: Ensure that all documentation complies with FDA, ISO, and other applicable regulatory requirements and industry standards.
Review and Revise: Perform comprehensive reviews of documentation including quality system documents (Labeling SOPs), incorporating feedback from regulatory and quality assurance teams to enhance clarity and compliance.
Document Management: Maintain version control and ensure that the most current documentation is accessible and properly archived for audits and regulatory submissions.
Qualifications
Education: Bachelor’s degree in Technical Communication, Regulatory Affairs, Life Sciences, Engineering, or a related field.
Experience: 5 years of experience in technical writing, preferably in regulatory affairs or the medical device sector.
Knowledge: Familiarity with medical device regulations (FDA, ISO 13485, ISO 14971, and ISO 15223-1) and experience in creating regulatory documentation, including IFUs. Familiarity with clinical data, digital design, and pharma/combo medical devices.
Skills:
Exceptional writing, editing, and communication abilities.
Proficient in documentation tools such as Adobe InDesign, or Microsoft Word.
Strong attention to detail, with the ability to manage multiple projects simultaneously.
Analytical Skills: Capable of analyzing complex technical information and translating it into clear, concise documentation.
Competencies and Skills
Strong written, organizational, verbal and project management skills
Ability to work effectively in cross functional teams
Must be able to manage multiple and competing priorities and manage programs with minimal oversight
Enjoy collaborating with others and create alignment with team members
Ability to work independently and lead technical writing projects.
Strong technical skills, critical thinking, and sound decision making.
Pay / Compensation
The expected pre-tax pay rate for this position is $66,000 – $88,500
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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Job Locations US-CA-Irvine
ID 2024-3187
Category Quality/Regulatory
Position Type Regular Full-Time
CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact GlobalHR@Cordis.com