High Wycombe, Buckinghamshire
We are a leading Medical Device company and due to continued growth, we have an exciting opportunity for a Regulatory Affairs Specialist to join our highly motivated team.
As our new Regulatory Affairs Specialist, you will be responsible for supporting the Quality Management Systems within the business ensuring compliance to ISO 13485, Medical Devices Regulations and other ISO standards. To work closely with Senior Management to develop and deliver a range of proactive and responsive processes to maintain compliance
This is a fantastic opportunity for an experienced Regulatory Affairs Specialist from a Medical Device background or knowledge of Medical Device standards and regulations, who is looking to join an innovative and successful company.
To be successful in this role we’re looking for the Regulatory Affairs Specialist to have the following skills, experience and knowledge
*Degree in Life Sciences, Pharmaceuticals, Engineering or related subject
*Proven Regulatory experience from medical devices/pharmaceutical field
*Ability to demonstrate Regulatory knowledge (MDD) in Class I and Class IIa devices as a minimum
*Hands on experience of creating and maintaining technical files in accordance to MDD/MDR
*Experience of working with ISO 13485 and ISO 14971
*Experience of dealing directly with Notified Bodies and Competent Authorities such as MHRA
*Internal auditing experience
*Experience of dealing with Post Market Surveillance
*Experience of auditing to ISO 13485/ISO 9001
*Strong analytical and problems solving skills
If you have the skills, knowledge and experience to be successful in this role, please click apply now or contact Kris Holmes on (phone number removed).
Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.
By applying for this position please take a few moments to view our Privacy Notice on our Orion website which details how we retain and process your data. Alternatively please give us a call so we can discuss this with you