Regulatory Affairs Consultant

Location: Inverness, Highlands Salary: £40 - £42.50 per hour
Sector: Medical Devices Type: Contract
Contact: Sam Davies Job Published: about 1 month ago

Regulatory Affairs Consultant

Regulatory Affairs Consultant needed for a globally-recognised medical devices organisation based in Inverness who are looking to employ an experienced Regulatory Affairs Consultant with an in-depth knowledge of the medical device industry.

The successful Regulatory Affairs Consultant will want to work for this client not just because it's a great opportunity but also because they will receive a pay rate of up to £42.50 per hour.

What the role entails: This role will be providing RA leadership on product lifecycle management (change management) and global product registrations.

Some of the main duties of the Regulatory Affairs Consultant will include:

Lifecycle management:

* Partners with in-country global regulatory affiliates to complete global impact assessments for changes to existing products.
* Consolidates global regulatory feedback and communicates requirements to change owners/project team.
* Participates as RA lead in cross-functional project teams for significant change projects, provides input to verification and validation planning and approves documentation associated with the change.
* Completes required regulatory activities for US & EU to implement the changes.
* Reviews and approves product labelling.

Global Product Registrations:

* Partners with in-country regulatory affiliates to understand registration requirements for new product registration and lifecycle license maintenance (change registration, renewals) for existing products.
* Provides documentation to in-country regulatory affiliates for registration filings.
* Researches, consolidates and communicates changes to global regulatory requirements to RA team and cross-functional business partners.
* Provides support for initiating and tracking impact assessments for revisions to technical standards and Guidance documents.
* Assists in the development of best practices for Regulatory Affairs processes
* Provides support for other regulatory activities as required

What you need to be the successful Regulatory Affairs Consultant:

* Significant Regulatory Affairs experience within the medical device industry with knowledge of IVD or MD regulations in US and/or EU (ideally compiling and submitting EU CE File and US 510(k) pre-market submissions)
* Demonstrated understanding of Design Control;
* 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 really is a fantastic opportunity for a Regulatory Affairs Consultant to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!

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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