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Regulatory Affairs / Senior

Location: Inverness, Highlands Salary: £28 - £39 per hour
Sector: Life Sciences, Pharmaceuticals, Medical Communications, Medical Devices Specialism:
Type: Contract Contact: April Burton

Regulatory Affairs / Senior

Inverness

12 month contract

£28-£39 per hour

Regulatory Affairs / Senior needed for a leading medical devices company based in Inverness. My client is looking for an experienced Regulatory Affairs / Senior with previous medical device experience and knowledge of IVD or MD regulations.


My client will be offering the successful Regulatory Affairs / Senior a competitive hourly rate (£28-£39 per hour) for a 12-month contract working at their ever-growing site in Inverness.


Some of the main duties of the Regulatory Affairs / Senior 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 labeling.

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.

What you need to be the successful Regulatory Affairs / Senior:

  • 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
  • Strong organisational, 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 contract opportunity for a Regulatory Affairs / Senior working with a leading medical device company. Don't miss out, apply now!

Regulatory Affairs / Senior

Inverness

12 month contract

£28-£39 per hour

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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