RA Leader - Leading Pharma - Cutting-Edge Devices - Dublin

Our client, a leading Pharmaceutical company, well-known for its innovative power and with activities worldwide, is looking for a Regulatory team leader for their Medical Device division in Dublin, Ireland.

This is a very exciting time for an experienced Regulatory Affairs professional to join a company that has been expanding massively its medical device portfolio (especially with combination devices) while having a strong impact on millions of patients around the world.

This is a perfect opportunity for you to bring in your expertise in Regulatory Affairs, being sure that you will leave your mark on the organization and share your expertise with a cross-functional team to help them grow and develop. In other words, you will be responsible for ensuring compliance with worldwide regulations to reach sucessful submissions (mostly CE marking and FDA) by maintaining a close link with the Clinical, Regulatory, Labelling and other teams involved from the development phase of cutting-edge devices.

Are you ready to be a game changer?

Your missions will include but not be limited to:

- Being the expert for FDA, EU and ISO standards and regulations related to design control and regulatory strategy

- Building and maintaining competitor intelligence on device and combination product submissions and approvals

- Developing strategies and plans that ensure compliance to regulations, legislations and standards

- Developing technical briefing documents on device development and regulatory plans.

The Ideale Candidate will have:

- 5+ years of Regulatory Affairs experience within the Medical Device Industry (experience with Combination devices would be an asset)

- Solid knowledge of device design controls

- Strong experience with ISO 13485 /FDA and CE requirements applicable to Medical Devices

- Fluent English

Call me now, Remi Gourmel at NonStop Recruitment for a confidential conversation. Contact me on r.gourmel@nonstop-devices.com or +44 207 940 2116, please send your CV in Word format.

OR if this does not sound like the opportunity for you, but you are a Regulatory Affairs or Quality Assurance professional within the medical device industry, please feel free to get in touch, to see other opportunities we may have within this field.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.