Support regulatory activities, including preparation and submission of product registrations for medical devices and IVDs to HSA and other regulatory authorities (e.g. EU IVDR, FDA).Assist in ensuring compliance with app…
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Full-time
bachelor degree
Posted 1d ago
~40 hrs/week
Responsibilities
Support regulatory submissions and product registrations for medical devices and IVDs with authorities like HSA, FDA, and EU IVDR. Maintain and improve the Quality Management System (QMS) while ensuring compliance through audits and documentation control.
Requirements
Requires a Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field. Candidates must have at least 2 years of relevant experience in Regulatory Affairs or Quality Assurance within the medical device or IVD industry.
Full job description
Support regulatory activities, including preparation and submission of product registrations for medical devices and IVDs to HSA and other regulatory authorities (e.g. EU IVDR, FDA).
Assist in ensuring compliance with applicable regulatory requirements and standards across all markets.
Support post-market regulatory activities, including product renewals, vigilance reporting, and change notifications.
Assist in maintaining and improving the Quality Management System (QMS) in accordance with ISO 13485, GDPMDS, and other applicable standards.
Ensure quality processes and documentation are aligned with regulatory requirements.
Prepare, review, and maintain quality and regulatory documentation, including SOPs, work instructions, and records.
Support internal and external audits (e.g. regulatory inspections, certification audits), including audit preparation and follow-up on corrective and preventive actions (CAPA).
Coordinate with cross-functional teams (e.g. R&D, Operations, Supply Chain) and suppliers to ensure compliance with regulatory and quality requirements.
Provide support on regulatory and quality matters to internal stakeholders when required.
Assist in conducting training on regulatory and quality topics.
Support continuous improvement initiatives for QMS and regulatory compliance processes.
Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
At least 2 years of relevant experience in Regulatory Affairs and/or Quality Assurance within the medical device or IVD industry.
Basic knowledge of HSA regulations, ISO 13485, GDPMDS, and familiarity with EU IVDR and FDA QSR.
Exposure to regulatory submissions and product registration is an advantage.
Understanding of QMS processes, documentation control, and CAPA is preferred.
Good organizational, communication, and coordination skills.
A global diagnostics organization delivering answers when you need them most.
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Founded
2006
Headquarters
Alpharetta, Georgia
LinkedIn followers
29,393
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.
#Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Offices: 5900 Windward Pkwy W, Alpharetta, Georgia 30004, US · 9540 Waples St, Unit C, San Diego, California 92121, US · Beijing, 102433, CN · Dubai, AE
Health DiagnosticsHealth CareMedical DeviceMedical