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Regulatory Affairs Specialist

2 weeks ago

Dublin, Dublin City, Ireland Life Science Recruitment Full time

Job Description:

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  • Company Overview

We are Life Science Recruitment, a leading recruitment agency in the medical device industry. We work with clients to find top talent for their teams.

Role and Responsibilities

This role requires an experienced Senior Regulatory Affairs Specialist to join our client's team. The successful candidate will be responsible for developing regulatory strategies, interacting with regulatory bodies, and maintaining design history files.

The ideal candidate will have a strong knowledge of quality management systems, design controls, and current international and European regulations/standards related to medical devices.

Required Skills and Qualifications

To be successful in this role, you will need to possess excellent leadership and project management skills, as well as good communication skills.

You will also need to have a Bachelor degree in science, engineering or a related field, and at least 5 years of experience in medical device regulatory affairs.

Benefits

As a Senior Regulatory Affairs Specialist, you will have the opportunity to work with a high-potential medical device start-up company developing innovative cardiovascular devices.

You will also have the chance to contribute to the development of a robust and compliant quality system, and to support the preparation for inspections by notified bodies and regulatory authorities.