Regulatory Specialist

  • Location
    Stoke-On-Trent, Staffordshire
  • Salary
    £ 35000 - £ 40000 / Year
  • Job type
    Permanent
  • Industry
    Engineering
  • External Reference
    54371
  • Category
    Medical & Health - Optics

Title: Regulatory Specialist


Location: Stoke on Trent


Contact:



Do you want to work in a friendly company where you can get to know everyone?
Are you feeling limited in your tasks and your scope?
Are you an experienced Regulatory Specialist in the medical device industry?
If yes, look no further!



The Company


This company is a business with a singular focus, on manufacturing and engineering products to improve patients' lives.


With over 25 years of experience in their market and having sold their product globally in over 40 countries, the success of the business goes from strength to strength.


With manufacturing in the UK, you will be based at the core of the business.


This is a fantastic opportunity to join a company and a team with a close-knit working culture, a passion for quality and regulatory and the support to inspire their employers to reach their full potential.



The Opportunity:


In this role as Regulatory Specialist, you will have the chance to work alongside a motivated team on technical file remediation to ensure MDD to MDR compliance and support the business in global product submissions, as they have big plans to enter new markets.


If you are looking for a position where you can make a difference, develop existing skills and learn new skills whilst working collaboratively with other departments such as quality, validation, production etc, look no further.



Requirements:


As a Regulatory Specialist you will (not an exhaustive list):


Create and maintain Technical Files in accordance with EC Regulation 93/42/EEC.

Transition Technical Files from Medical Devices Directive (93/42/EEC) to Medical Devices Regulation (2017/745)

Compile Technical Files and documentation for review by the Notified Body.

Provide regulatory support for all post-market surveillance activities.

Maintain and approve product labelling to meet regulatory & UDI requirements.

Review marketing, promotional material, and website content for regulatory compliance.

Manage and maintain global distributors including UK, Europe, Japan and USA.


Requirements


3+ years of Regulatory experience in the Medical Device industry


Previous experience working with technical files


Fluent written and speaking skills in English


Experience working within a manufacturing environment



Interested in a further conversation? Please apply to this advert or also send your CV to arrange a confidential career discussion.

Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

To speak to a recruitment expert please contact Amy Holder