Career Advancement Programme in Medical Device Regulations
-- viewing nowMedical Device Regulations training is crucial for professionals aiming for career advancement in this highly regulated industry. This programme equips regulatory affairs, quality assurance, and clinical affairs professionals with in-depth knowledge of medical device compliance.
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Course details
• Quality System Regulations (QSR) and ISO 13485
• Risk Management in Medical Device Development
• Regulatory Submissions and Approvals (e.g., 510(k), PMA)
• Post-Market Surveillance and Vigilance
• Medical Device Law and Compliance
• International Medical Device Regulations (e.g., EU MDR, Canadian Medical Devices Regulations)
• Human Factors Engineering in Medical Device Design
• Cybersecurity in Medical Devices
Career path
Career Advancement Programme: Medical Device Regulations (UK)
Job Title | Description |
---|---|
Regulatory Affairs Specialist (Medical Devices) | Ensure compliance with UKCA and MDR regulations. Develop and implement regulatory strategies. High demand for experience with notified bodies. |
Medical Device Auditor | Conduct internal and external audits to ensure compliance. Strong knowledge of ISO 13485 and other relevant standards is crucial. Excellent career progression opportunities. |
Quality Assurance Manager (Medical Devices) | Lead quality management systems, ensuring product safety and regulatory compliance. Requires strong leadership and problem-solving skills within a regulated environment. |
Clinical Affairs Specialist | Manage clinical trials and post-market surveillance activities, working closely with regulatory bodies. Experience with clinical study design and data analysis is highly valued. |
Entry requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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