My client is looking for a Regulatory Affairs Specialist to join their ever-growing team.
You will be working with the latest technologies across a broad portfolio of products which includes Programmable Electrical Medical Devices, stand-alone software as medical device, and disposable infusion sets
You will be a regulatory expert and particulate in cross-functional teams.
- Input the develop regulatory strategies.
- Communicate and compile regulatory requirements to cross-functional groups (MDD/MDR).
- Prepare gap analysis assessments of regulations to cross-functional groups.
- Review and approve project documentation.
- Develops tactics to market commercial opportunities and minimizes time to product launch.
- Level 8 (relevant degree).
- 3 years experience in a similar role.
- Experience working with regulatory submissions and would have exposure to programmable electrical equipment.
- Experience in EU MDR / EU MDD and standards (ISO 13485, ISO 14971 and IEC 60601 series).
For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / email@example.com
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