Real Staffing is a global leader in the provision of pharma, biotech and medical devices recruitment services. Working across Europe, the US and Asia Pac we are one of the world’s most extensive pharma, biotech and medical devices recruiters and have one of the largest networks of specialist recruiters globally. Within the UK, Real is also a leading specialist in the provision of public sector, IT and engineering recruitment services, helping companies of all sizes find the new employee or team they’re looking for and candidates to find the next step in their career. By recognising talent and valuing relationships we are able to consistently deliver local, global and industry expertise which in turn ensures success time after time. Our consultants develop an in-depth understanding of client objectives and candidate motivations, to ensure the right people are being placed in the right roles. We call this approach #inspiredbyyou, because we're inspired by the life-changing work of the industry and are proud to play a part in it. www.realstaffing.com

Job description

Our client is an established medical device company operating worldwide to enhance patient outcomes with leading innovative medical devices. They are headquartered in the UK with a global network of subsidiaries supporting over 105 countries.

They manufacture a variety of medical devices and are looking to make a difference to patients working with clinicians around the world.

They are in the process of expanding the QARA team and looking to add a Senior Regulatory Affairs Specialist. This role could be site based, hybrid or remote working for those further away.

Responsibilities:

The Senior Regulatory Affairs Specialist will assist in the company's transition to EU MDR
Maintaining Technical files (Class Is, IIa or IIb) medical devices and technology
Provide inputs into key Design and Development projects
Assist the team in delivering key regulatory documents
Review and approval of relevant design changes inline with EU/FDA guidance
Contribute to SME topics during external audit
Assist partners with key documents for ext. registrations

Qualifications:

Ideally degree level education or equivalent practical work experience in Regulatory Affairs
History with medical devices
Knowledge of ISO 13485
Expertise with Urology or Respiratory Devices (although this is not a deal breaker)

Desired Skills and Experience

Regulatory Affairs, Medical Device, EU MDR, Technical files, Design & Development, FDA, Registrations

To find out more about Real, please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office |8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales

Required profile