Job Description
Senior Regulatory Affairs Specialist Post Market Location: Parkmore, Galway Overview:
The successful candidate will play a key role in the implementation of post-market activities for a fast-paced medical device company.
Reporting to the Senior Regulatory Affairs Manager, the Senior Regulatory Affairs Specialist Post Market will be responsible for the development and implementation of regulatory strategies to ensure compliance with international regulations.
This is an exciting opportunity for a senior regulatory professional to add value to the future success of the company by providing leadership and expertise in the field of regulatory affairs.
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Requirements
A degree level qualification in Engineering, Science, QA, or related field is essential. Minimum 5 years experience at a senior regulatory level in the medical device industry is required.
A minimum of 5 years' experience in creating regulatory submissions for premarket approval is necessary.
Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and FDA QSRs is a prerequisite.
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Benefits
Top salary, bonus, pension, healthcare, hybrid working opportunities available.
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Others
An excellent opportunity to work in a collaborative, empowering, and exciting environment.