Job Title:
* Regulatory Specialist
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Job Description:
We are seeking a highly skilled Regulatory Specialist to support the commercialization of Medical Device products. The ideal candidate will have a degree in Engineering or Science discipline and minimum 2 years' experience in the medical device industry.
The role involves preparing and submitting regulatory filings for product market entry and maintenance of existing commercial products. Strong technical aptitude, analytical skills, and ability to interpret and implement regulatory requirements are required.
In addition, the candidate should be able to maintain Technical Documentation according to the Medical Device Regulation and represent Regulatory Affairs within project teams to provide direction.
Furthermore, the Regulatory Specialist will provide regulatory input to customer complaint investigations and ensure that all submissions are compliant with FDA and/or MDR requirements.
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Requirements:
1. Degree in Engineering or Science discipline
2. Minimum of 2 years' experience in the medical device industry
3. Understanding of FDA and/or MDR requirements, with the ability to interpret and implement these requirements
4. Strong technical aptitude with an ability to analyze and challenge data, identify and address gaps, and generate technical reports to support submissions