Senior Regulatory Affairs Consultant

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Role: Senior Regulatory Affairs Consultant for a Medical Device Company

Location: Galway

Contract: 6-12 months

Company / Culture:

This company is a well -known medical device company located in Galway. Employees have excellent opportunities for learning and career growth and the company also has a culture of collaboration and open communication is promoted.

Your Background:

You have excellent understanding of regulatory strategy and determination of documentation requirements, timelines, budgets and filing options.

You also have experience with negotiating to identify and resolve issues and are highly organised. You would also know how to prioritise own work load and the work load of the project team to achieve project deliverables. You will also have a minimum 8 years' experience in regulatory affairs, ideally with Class III cardiovascular medical devices and have a Bachelor's or Master's degree in science, pharmacy, engineering or life-sciences related field.

What will you be doing?In this Senior Regulatory Affairs Consultant role you will be involved in

* Management of regulatory submissions to regulatory authorities for the company's products,

* Management of routine regulatory activities including clinical evaluation, safety and vigilance reporting and post market surveillance reporting.

* Maintenance of existing global regulatory approvals.

* Supervision and development of direct regulatory team members to ensure timely and successful achievement of regulatory goals.

* Provide a regulatory interface to the company's clinical and commercial operations.

* Develop and advise on regulatory strategies for existing and changing products in collaboration with R&D, Manufacturing and Quality Assurance departments, as appropriate.

If you are interested in this role please apply below with an updated CV. No CV ready? Want to hear more? Please feel free to reach out for more information.SThree UK and Ireland is acting as an Employment Business in relation to this vacancy.