Senior Regulatory Affairs Professional for Medical Device Product Registration
21 hours ago
**CorDx Opportunity:** We are seeking a seasoned Regulatory Affairs Executive to lead our medical device product registration efforts.
Job Description:We are looking for a highly skilled and experienced Regulatory Affairs Professional to join our team at CorDx. As a key member of our regulatory affairs team, you will be responsible for managing the product registration process for our medical devices in various regions.
Main Responsibilities:- Product Registration: Prepare and submit registration dossiers, design performance evaluation studies, and manage execution and communication with clinical research organizations (CROs).
- Laws and Regulations: Serve as the subject matter expert on medical devices laws and regulations for product registration in our target regions.
- Regulatory Agency Interface: Communicate with regulatory agencies, track progress, and resolve issues raised during review processes.
- Product Testing and Verification: Participate in product testing, clinical verification, data collection, and tracking.
- Scientific Projects: Submit scientific special projects on behalf of the company to regulatory agencies.
- Cross-Functional Collaboration: Establish working relationships with key opinion leaders and regulatory bodies, and collaborate with cross-functional teams to achieve project goals.
To succeed in this role, you must have:
- A bachelor's degree in Life Sciences, Pharmacy, or a related field.
- Familiarity with ISO 13485 quality management systems and solid medical device quality management qualifications.
- Expertise in medical device product registration laws and regulations, including experience drafting registration dossiers.
- Complete registration experience with Class B, C, and D medical devices.
- Familiarity with in vitro diagnostic products, such as lateral flow immunoassay, PCR, and immunoassay.
- Knowledge of IVD product development and commercialization life cycles.
- Strong project management skills, including planning, execution, and timely communication.
- Excellent presentation skills and the ability to handle stress and tight schedules.
We offer a competitive salary range of $120,000 - $150,000 per annum, depending on experience, plus benefits and opportunities for professional growth.
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