Regulatory Affairs Manager (Medical Devices)
Role and Company Overview:
A world leading Medical Device company are continuing to grow and are looking for a Regulatory Affairs Manager to come in and manage the team. The company produce a product of unrivalled ability, which has given them the lion's share of the market. You'll be part of a company that is going from strength to strength but always keeps the patient at the centre of their work.
Based near Edinburgh, you'll be given ownership of the Regulatory Affairs team, managing the Regulatory Affairs Associate and ensuring the company is kept up to speed with the ever changing Regulations. Experience of ISO 13485 is essential, and FDA experience is highly sought after, as a significant proportion of the company's business is carried out in America.
As Regulatory Affairs Manager, you'll help prepare and submit filings to FDA and other international and domestic bodies to obtain regulatory clearance for the product range. As a senior leader in the company, you'll also coordinate with international contacts on product changes and regulatory approval requirements, effectively communicating it to the RA team for implementation.
If you're looking for an opportunity that is going to take your Regulatory Affairs career to the next level, this could be the role for you.
- Good awareness of FDA & MHRA systems and procedures.
- Previous Knowledge of ISO 9001/13485 system
- Knowledge of GMP / Quality System Regulations
- Experience (even in an informal setting) of team management
Location: Near Edinburgh
Start date: ASAP
If you would like to express interest, please get in touch with a copy of your latest CV, detailing your experience within the areas above and call in for Dan Abbott to discuss the application process
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 Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales