Regulatory Affairs Specialist Medical Devices

Exciting opportunity for an experienced Regulatory specialist with experience in Regulatory Affairs and FDA to join a global medical device company based in Leeds, UK offering a salary in the region of €50-€60K + benefits

As a regulatory specialist you will be supporting all registration activities, CE marking and regulatory submissions as per project requirements.

Working as part of a global team your responsibilities as a Regulatory specialist will be:

• Facilitating worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
• Ensuring post-marketing surveillance responsibilities are fulfilled and support vigilance activities.
• To maintain information on worldwide regulatory requirements and the status of product registrations.
• To Review technical documentation created by teams based remotely and ensure these are complete and accurate.

Background Experience

• A graduate engineering/science degree.
• Good experience in Regulatory Affairs, preferably in Medical Devices.
• Knowledge and experience in EU and FDA regulations
• Regulatory Affairs certification (like RAC) is beneficial
• Strong knowledge in the application of MDD93/42/EEC
• Exposure to change management

The Offer

This Regulatory Affairs Specialist role offers a competitive package in the region of €50000-€60000 based on relevant experience along with a bonus, healthcare, pension, education support +++ with excellent career advancement opportunities.

To apply for this Regulatory Specialist role email CV in the strictest of confidence to Som in Principle on som@principlehr.ie or call 0035316035075 | 443300526074