Senior Regulatory Affairs Consultant - Medical Devices - Exclusive - Home Working
Position: Senior Regulatory Affairs Consultant - Medical Devices - Exclusive - Home Working
Location: , United Kingdom
Remuneration: GBP 60,000 - GBP 130,000 per annum
Vado Med Tech are retained as the exclusive partner for a multi-award-winning Consultancy that employs over 900 staff worldwide with a culture focused on excellence, continuous improvement and collaboration. They have a unique position in the Consulting space with physical laboratory services, clinical research teams in addition to Consulting services bringing devices to market across the world.
Due to continued expansion and customer demand they are appointing an additional Biocompatibility Specialist to their existing Biological Safety team of around 10 who work remotely across Europe in either the UK, France or Germany. They have an unrivalled presence in the medical device, human tissue and IVD space and have already made substantial investments in the European infrastructure to support and facilitate this growth.
As Regulatory Affairs Consultant you will provide expertise to multiple UK and European medical device clients on pre-market submission strategy (510k, CE, PMA, PMA-S) for European and global regions. This strategy could be with, or without clinical trial. You will also likely look at projects including QMS work, transition to the MDR and therefore should have a thorough understanding of MDD 93/42. It is not expected that you be an authority in everything regulatory as this is unrealistic. Any specialist knowledge in areas like IEC62304, IEC60601, usability, labelling and human factors would be beneficial to the existing team. To assist with the considerable documentation involved our client has an entire supporting team of Medical Writers that work directly with the Consulting resources to assist in the compilation of DHF’s, CERs etc. This enables the Consultants to focus on Consulting and add real value to the client experience.
In addition to Consulting, our client is keen for staff to be engaged with the industry and be prepared to speak at events and contribute to marketing material. If you have direct experience as a subject matter expert, or public speaker this would be something our client embraces and encourages. They have a considerable presence at most showcase events.
Culturally the company stand out as modern and forward thinking. Communication is open and despite their size there is no ‘corporate feel’ to this organisation. Their staff are empowered, encouraged to learn, develop and collaborate and have a focus on their expertise directly benefiting patients. Most of the staff have seen considerable progression or diversification in their roles and are actively encouraged to put forward new ideas to the business.
To be considered for this position you should have:
- 10 years + in Medical Device Regulatory Affairs
- A high level of competence with MDD93/42
- Experience with High risk devices class IIb, III
- Lead pre-market submissions into Europe and the USA (CE, 510k
- Sound understanding of ISO13485:2016
As Regulatory Consultant you can work from home, collaborating with a global team and clients via webex. It is expected there will be around 20% travel per month, which will be planned and managed by you in most instances. Remuneration is very competitive with packages going up into six figures, annual bonus, healthcare, dental etc. Full details are available on application.
Initial meetings with the client will be conducted after the holiday period in September. A Consultant from Vado Med Tech will contact you within 5 days of your application with a view to setting up a Skype meeting to discuss the position and your experience. Please note that we do require a full CV before we will discuss this with you in full.