Regulatory Compliance Specialist

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Based in Dublin, this is a newly opened role for a Regulatory Compliance Specialist in a leading medical technologies manufacturer (salary EUR45-50K).

Due to recent expansions and continued project success, the role of regulatory compliance specialist has become available today.

Commutable from Kildare, Meath and Wicklow.

As a regulatory compliance specialist, you will be supporting the Regulatory Compliance Manager:

1 To ensure compliance with Global regulatory and quality requirements for products

2 To ensure compliance to all vigilance and Post Marketing Surveillance requirements.

Key Responsibilities:

* Assist with maintenance of current global product registrations in over 40 markets

* Help coordinate and compile documentation required to support regulatory submissions in new markets.

* Maintain the day to day activities of Post Market Surveillance and Global vigilance system, including, but not limited to:

- logging customer complaints and adverse events;

- coordinating investigations between complainants and contract manufacturing sites;

- follow up corrective actions, when required and;

- compiling data for trend analysis.

Performing proactive searches for data including customer surveys

* Maintain and coordinate quality system schedules, including:

- Supplier and internal audits;

- management review and;

- documentation updates.

* Prepare quality and regulatory documentation for review and approval by the Regulatory Compliance Manager.

* Carry out other regulatory and quality related duties as required.

Requirements of the quality/regulatory position:

* Primary degree in life sciences is a requirement

* Previous experience in medical device or pharmaceutical industry in either regulatory or quality (2 years min)

Benefits to you:

* Excellent scope within the position

* Benefits package

* Clear internal progression structure

* Speedy interview process

Those with medical device & pharmaceutical experience are being considered!

Apply today for immediate consideration!