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Medical Technologies Regulatory Affairs & Quality

Your Course
The Level 8 Certificate in Medical Technologies Regulatory Affairs and Quality provides students with an introduction to the core elements of the product development life cycle and the associated role of a Medical Technology Regulatory Affairs and/or Quality professional. The programme ensures that students acquire a good, fundamental understanding of all applicable regulations and skills to address the ever-changing environment of Medical Technologies Regulatory Affairs and Quality.

The programme aims are to:
• Provide participants with a fundamental grounding in medical device regulatory and quality requirements;

• Provide necessary training to convert personnel with life sciences qualifications to transition into specialist roles in medical technology quality assurance and/or regulatory affairs functions and upskill medical technology professionals in the regulatory framework in their existing roles;

• Foster participants' intellectual development and develop skills to work and communicate effectively through various media.

Entry requirements

Minimum Entry Requirements
Students with a Level 7 or higher qualification in Science or Engineering are eligible for the proposed Level 8 programme. Students with a Level 7 or higher qualification in a non-technical subject area but who hold a minimum of 5 years relevant medtech industrial experience in regulatory affairs or quality are eligible for the Level 8 programme.

Duration

1 Year (2 semesters); part-time distance-learning.

Careers or further progression

Career Opportunities
The Irish Medtech Association (IMA) Skillnet asked senior medtech industry executives to identify the current number of employees required to meet current skills demand, as well as forecasted number of employees required in medtech organisations up to 2020. The IMA report (2017) has estimated that 4,000 additional medical technologies jobs will be added by 2020, with a 43% increase in staff numbers in the regulatory affairs functions and 17% in quality roles.

Further enquiries

Professor Terry Smith
T: +353 91 492 022
E: terry.smith@nuigalway.ie

Comment

3 Good Reasons To Study This Course
1. Regulatory Affairs and Quality professionals at all career and experience levels are involved in activities throughout the product life cycle, and most are involved to some degree in bridging the gap between regulatory-related functions and organisation and business activities.

2. This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs environment within the highly successful and growing Irish medical technology industry sector.

3. Completing this course will open up a new opportunities and career paths, in Quality and/or Regulatory Affairs, in both Irish-based and international medical technologies enterprises.

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