Regulatory Affairs Specialist
1 month ago
CorDx is seeking a highly skilled Regulatory Affairs Executive to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with medical device regulations and laws in our regions of interest.
Key Responsibilities:- Product Registration: Prepare registration dossiers, design performance evaluation studies, and manage execution and communication with CROs.
- Regulatory Expertise: Be the subject matter expert on medical devices laws and regulations for product registration in our regions of interest.
- Regulatory Interface: Communicate with regulatory agencies, track progress, and resolve problems raised by reviewers.
- Product Testing: Involve in product testing, clinical verification, data collection, and tracking.
- Scientific Projects: Submit scientific special projects to agencies on behalf of the company.
- Collaboration: Establish collaborative relationships with key opinion leaders and regulatory bodies.
- Team Collaboration: Collaborate with cross-functional teams to meet project goals and organizational objectives.
- Education: Bachelor's degree in Life Sciences, Pharmacy, or a related field.
- Quality Management: Familiar with ISO13485 quality management system and solid medical device quality management qualifications.
- Regulatory Expertise: Expert in medical device product registration laws and regulations, able to independently draft registration dossiers.
- Registration Experience: Complete registration experience of Class B, C, and D medical devices.
- IVD Products: Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, and Immunoassay.
- Project Management: Systematically project management, good planning, execution, and timely communication.
- Soft Skills: Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
- Responsibility: Meticulous and strong sense of responsibility; able to handle stress and tight schedule.
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