Assistant Manager / Manager, Regulatory Affairs
About CorDx:
CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.
CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.
With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.
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 Responsibilities
- Lead product registration: including preparation of registration dossier, design of clinical trial and manage execution and communication with CRO (clinical research organization);
- Be the expert on laws and regulations for product registration in company’s regions of interest;
- Interface the communication with regulatory agencies, e.g. Food and Drug Administration, track the progress of product registration, and resolve problems raised by experts during the review process;
- Lead the process of product testing, clinical verification, data collection and relevant tracking;
- Submit to agencies scientific special projects on behalf of the company;
- Guide the company’s audit review from regulatory bodies e.g. the Food and Drug Administration, lead the company's internal review, and participate in the operation and maintenance of the company's various quality management system.
- Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies;
- Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
- Any other ad-hoc duties or projects as required by the management team.
Qualifications:
- Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class II and III medical devices;
- Expert in medical device product registration laws and regulations, able to independently draft registration dossier;
- You shall have complete registration experience of Class II and Class III medical devices;
- A bachelor's degree with 7 years of relevant experience, a master's degree with 3 years of relevant experience, or a doctorate degree with at least 1 year of relevant experience. Others are welcome to apply.
- Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc;
- Familiar with IVD product development and commercialization life cycle;
- Systematical project management, good planning, execution and timely communication. Good presentation skills.
- Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred;
- Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player;
- Meticulous and strong sense of responsibility; able to handle stress and tight schedule;
How to Apply:
- Please send a comprehensive resume, a cover letter (If applicable), along with your current and expected salary and send to foongying@cordx.com or apply @ My Careerfuture.
- We regret that only shortlisted candidates will be contacted
