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Senior Regulatory Affairs Leader

Location: Inverness, Highlands Salary: £35 - £39 per hour
Sector: Client Delivery, Life Sciences, Regulatory Affairs, Pharmaceuticals, Medical Devices Specialism:
Type: Contract Contact: Dominic Martin

A fantastic opportunity has arisen for a Senior Regulatory Affairs Leader looking to fast-track their career to the next level with one of the world's leading Pharmaceutical & Medical Device manufacturing companies based in Inverness in Scotland! The organisation is a world leading Medical Device company and they're known throughout the world for its ground breaking products, helping save the lives of millions and improve the well-being of others!

You as the Senior Regulatory Affairs Leader will supporting the Regulatory Affairs Project Leads with some of their latest projects in Blood Glucose Monitoring Systems!

On offer to you is:
* An initial 12 month contract, highly likely for the contract to be extended
* An hourly rate up to £39.00 per hour and a 37 hour working week
* The option of using my clients latest modern facilities, there's a gym and canteen available to staff
* A great opportunity to fast-track your career with one of the top 3 global leaders in the manufacture of Healthcare, Medical Devices & Pharmaceutical products, they're one of the best recognised companies in the industry!

Duties & Responsibilities required for the Senior Regulatory Affairs Leader position:
* Researching, consolidating and communicating global regulatory requirements to enable development of global regulatory strategies.
* Providing RA input and leadership during characterization, verification & validation, labelling & claims development.
* Partnering and co-ordinating with other Regulatory Affairs Program leaders for other new product development projects as required.
* Preparing pre-market applications to US and EU regulatory agencies.
* Partnering with regional/country regulatory leads to support international applications for the new product.
* Identifying and driving the development of best practices for Regulatory Affairs processes.

Job Specific Skills & Experience for Senior Regulatory Affairs Leader position:
* Significant Regulatory Affairs experience within the medical device industry with knowledge of IVD or MD regulations in US and/or EU
* Demonstrated expertise in new product development; and compiling and submitting EU (CE File) and US (510(k)/PMA) pre-market submissions
* Degree qualified, preferably in a scientific or technical field
* Excellent verbal and written communication skills
* Strong organizational, interpersonal, and problem solving skills; detail oriented
* Ability to work independently and collaboratively with minimal supervision
* Working knowledge of MS Office programs (Word, Excel, PowerPoint, Outlook) and electronic document management systems


This is an exciting opportunity with a globally recognised organisation, one of the top 3 global leaders in the manufacture of Healthcare, Medical Device & Pharmaceutical products, operating in most healthcare and medical related industries! They're offering the chance for a Senior Regulatory Affairs Leader to join them on an initial 12 month contract basis with views for extensions! They're offering up to £39.00 per hour for the position and will be based at one of their leading Medical Device sites in Inverness, Scotland!

How to apply:
To discuss progressing your application for the position please apply for the role online and Dominic Martin at Gold Group Ltd will be in touch with you shortly to discuss the next steps of your application.

This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for interview.

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