Senior Regulatory Affairs Specialist - Deeside

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I am partnering a large, global Medical Device organisation, operating in over 100 countries on a newly created Senior Regulatory Affairs Specialist position based on their Deeside site. This is a company that has positioned itself to gain market share and have rolled out a number of exciting projects to give them a competitive edge along with having a solid pipeline of innovative products.

The organisation has heavily invested in its Learning and Development programmes and presents a fantastic opportunity to grow within the company, gain exposure to other product areas, work on NPD projects and get well rounded Regulatory experience on a global scale. Travel will be project specific but minimal (~5%).

This is a global role that will involve both Pre and post market Regulatory skills but more focused on pre-market work. The primary responsibilities of the position are to ensure regulatory compliance of the designated products globally, drive regulatory processes and activities (such as change control) and management of global and regional regulatory projects, including, but not exclusively, new product development, product life cycle and regulatory processes. There will be a focus on developing strategies and document preparation for products marketed in the US and EU. Additional responsibilities will include the mentoring of 2 junior team members as well as deputising for the Manager.

Key Responsibilities:

* Creation, development and maintenance of high quality regulatory compliant documentation for EU market and Class II/Unclassified products for the US market

* For medical device products under development liaise with Project Development teams to ensure regional RA requirements are included in the project plan and prepare the pre-marketing documentation (e.g. for CE marking and 510k) according to the agreed timeline and achieve regulatory clearance

* Creates new and innovative ways of doing things, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment.

* To assist with global regulatory processes, such as Change Control, GMDN, etc

* Assisting on NPD Projects

Required Skills & Experience

* Demonstrated Regulatory Affairs experience in Medical Devices

* Hands on experience of creating documentation compliant with EC Medical Devices Directive 93/42/EEC and FDA CFR 820

* Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971

* Demonstrate excellent communication skills

* Demonstrate solid organisational skills, including the ability to prioritise workload

* Excellent interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial

If this is something that aligns with your next career move, apply now or email me - l.fenlon-billson @ realstaffing.com

Sthree UK is acting as an Employment Agency in relation to this vacancy.