Regulatory Affairs Specialist (Medical Devices)

The Company

Our client, a global Medical Device company are seeking an entry level Regulatory Affairs Specialist to join their expanding team based in Livingston, Scotland. This position will provide you the opportunity to work with a market leader which has a presence in over 90 countries worldwide.

The Position

As the new Regulatory Affairs Specialist, you will support the Regulatory Affairs Team on Policy & Intelligence to assess the impact of changing regulatory requirements on the ongoing compliance of a product portfolio. You will also support the development of regulatory strategy for the Medical Device portfolio in international regions.

As part of the remit you will also:

• Work cross-functionally with change owners and global Regulatory partners to plan global regulatory submissions and approvals.
• Perform annual review of CE marking Technical files.
• Co-ordinate and support Standards Management Process including monitoring and gap assessment completion.

The Person

The ideal candidate will be degree qualified with a BA or BS degree or a MS degree with relevant experience. You will also have a minimum of 2 years' experience within the field of Medical Devices working with a Medical Device company or CRO.

As a Regulatory Affairs Specialist, you will also possess the following characteristics:

• Excellent grammatical, editorial and proof-reading skills.
• Organisational and time management skills with a strong attention to detail.
• Analytical skills, including analyses and problem solving.

Compensation

Market leading salary and benefits package.

To discover more about this opportunity, apply now or contact Josh Thompson on 0203 189 0487 or email jthompson@I-Pharmconsulting.com for a confidential discussion.