Job Description
Job Description
Who is CorDx
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more.
CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Job Type : Full time
Job Title : Regulatory Coordinator
Location : Onsite - San Diego
Salary Range : $66,560 - $75,000
Requirements
- Assist in the preparation, compilation, submission, and maintenance of regulatory filings and registrations, including DeNovo and 510(k) submissions for IVD products.
- Maintain and organize regulatory documentation, including regulatory submissions, approvals, certificates, and correspondences with health authorities.
- Work closely with R&D, quality assurance, and manufacturing teams to obtain required documentation in compliance with regulatory guidelines and product development life cycle.
- Maintain current knowledge of relevant regulations, guidance documents, and standards.
- Provide administrative and project support to the Regulatory Affairs team, including scheduling meetings, preparing agendas, and drafting regulatory reports.
- Support internal audits and assist in maintaining compliant regulatory documentation according to Quality Management System and in accordance with ISO 13485 and other relevant standards.
Requirements :
- Bachelor's degree in biology, chemistry, regulatory affairs or a related field.
- 2+ years of experience in regulatory affairs, preferably in IVD or medical device industry.
- Familiarity with FDA regulations, including 21 CFR, 510(k), and ISO 13485 requirements.
- Strong organizational and project management skills.
- Excellent written and verbal communication skills.
- Ability to work collaboratively with cross-functional teams.
- Detail-oriented with strong analytical skills.
Benefits
Medical Insurance Plan
Retirement Plan
Paid Time Off
Training & Development
We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams.
We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.
Regulatory Coordinator
The Regulatory Coordinator is part of the Research and Development team (R&D). The Rare Beauty Regulatory Coordinator is highly organized, has a strong attention to detail, is comfortable using software systems, and enjoys a fast-paced work environment. R&D is responsible for assessing ingredient sa...
Regulatory Coordinator
Job Title: Regulatory Coordinator. Maintain and organize regulatory documentation, including regulatory submissions, approvals, certificates, and correspondences with health authorities. Provide administrative and project support to the Regulatory Affairs team, including scheduling meetings, prepari...
Coordinator, Regulatory & Accreditation Programs - Regulatory & Accreditation
In collaboration with the Director of Regulatory and Accreditation Programs, assists in all accreditation & regulatory activities, including survey preparation & readiness assessments for all facilities accredited by the Joint Commission. The position is very independent & deals with sensitive and c...
Regulatory Coordinator - Hybrid - 127571
Under full supervision of the Regulatory Affairs Manager, the Clinical Trials Regulatory Coordinator I is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators at the Cancer Center. The Regulatory Coordinator I will act a...
Regulatory Coordinator
Job Title: Regulatory Coordinator. Maintain and organize regulatory documentation, including regulatory submissions, approvals, certificates, and correspondences with health authorities. Provide administrative and project support to the Regulatory Affairs team, including scheduling meetings, prepari...
Clinical Research Coordinator II - Pediatric Neonatology - Full-Time, Hybrid
The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Clinical Research Coordinator II - Pediatric...
Information Technology Project Coordinator
Projecting resource requirements, ensuring appropriate assignment of resources to each project/support phase, adding and deleting resources as necessary, and has overall responsibility for completion of the project. Responsible for developing and managing detailed project budgets and schedules, stat...
Environmental Project Coordinator
Ultimate Staffing is seeking an Environmental Project Coordinator to join a growing company in Foothill Ranch, CA. Provide customer service support consisting of but not limited to project communication and status updates. Prepare and distribute field documentation to project team. ...
CONTRACT | Privacy Program Manager
Substantial experience as a privacy program manager. Work with privacy counsel to develop, implement, and maintain comprehensive privacy compliance programs and policies, including creation and updating of process documentation and operationalizing privacy controls. Advise on and potentially contrib...
Regulatory Compliance Specialist
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of...