Medical Device Officer
Thornton & Ross “a company you can rely on”
AGILITY – do you have the flexibility and decisiveness to drive change?
ENTREPRENEURSHIP – will you thrive in one of the fastest growing pharmaceutical businesses in Europe?
INTEGRITY – we are driven by trust, respect and honesty, are you?
ONE STADA – communication and teamwork, it’s our path into the future together
About the Role:
This position will be key in managing, maintaining and preparing substance based dossiers in accordance with current/new UK and EU legislation, the regulatory compliance of Medical Device registrations in line with current legislation and to liaise with QA staff and Notified Bodies to effect updates and changes to internal regulatory systems accordingly. In addition, you will be liaising with other internal and external consultants to deliver necessary clinical, risk management, and periodic safety reports as may be necessary.
Co-ordination and preparation of necessary documentation and reports for Medical Device technical files and operation of the file review and maintenance system along with compliance activities for the Medical Device products. Regulatory participation in Medical Device Project work and Notified Body audits when necessary and supporting QA, to help ensure that our ISO 13485 accreditation is maintained.
To maintain a knowledge and familiarity with current regulatory requirements for all aspects of the job.
To support the Regulatory Manager in the reporting and analysis of the departmental performance and where required, attend appropriate industry regulatory meetings, such as the MHRA, PAGB or BSI.
Can you do it? Yes you can, if you’re keen to add value and see results, thrive under pressure and have the can-do spirit that’s spearheading our success, bring those qualities, with the following
- Degree in Life Sciences or equivalent.
- Ideally 1-2 years’ significant experience covering substance based Medical Devices.
- Proficiency in MS Word, Excel, PowerPoint etc. is essential.
What’s in it for you?
With 3 manufacturing locations in the UK, the Huddersfield site is the hub for our Zoflora® and Covonia® brands along with manufacturing some key medicines for the healthcare sector. This will give you the chance to be at a key site making an impact. We employ over 600 staff onsite, all of whom have the opportunity to progress as we focus on promoting from within and you can be part of that too. We offer competitive salaries, great benefits and a fantastic smelling work environment!