Medical QA and Regulatory Manager -the right time to join! (Permanent)

Location-Nottingham
Salary- £60,000
Benefits Package

*26 days holiday (additional 4days available to buy)

*Medical care

*10% pension scheme

*Life insurance (10 times amount of salary)

*Gym membership

*Cycle to work scheme and more!

My client is based in Nottingham and are working in the medical RnD sector, they have approx. 10 people on site, but are rapidly growing after being backed by a major player in the multi-national medical sector. After doubling in size last year, they are on track to do the same this year. Their growth plans include the globalisation of their products, already being distributed across 1000 sites in parts of Europe, Asia and North America they have plans to make this available worldwide.

In line with the leaps forward they are making as a company, they need a QA and Regulatory Manager to play a vital part in the globalisation of their one of a kind medical system. You should be experienced in regulatory submission, global standards compliance and design control for the medical sector or other highly regulated sector the product you will be overseeing includes elements in wireless electronic transducers, ECG electrode patch technology and wireless communications/ interfaces.

What will you be doing?

*Drafting of all technical documentation to obtain FDA 510k clearance
*CE marking technical files for new products including user manuals and labelling design
*Act as a design control manager within new product teams to execute plans according to committed timelines, while compliing to relevant regulatory and quality guidelines and company targets.
*Actively manage compliance risk
*Offer insight into standards and regulations for management and team members.
*Maintain customer focus and product quality vigilance.
*Utilize expertise in global medical regulatory standards to reduce overall global standards to actionable, quantifiable and testable technical product requirements.
*Arrange and manage testing for both new product regulatory submissions to 60601 and similar standards and to ensure ongoing compliance
*Arrange and manage testing for both new product regulatory submissions to FCC and RED standards and to ensure ongoing compliance

Your Skill Set

*Experience of preparing technical documentation for FDA 510k submissions
*Previous experience in CE technical submissions
*Risk assessments to ISO 14971
*Medical device electrical safety testing to IEC 60601-1 and FCC/ RED wireless standards
*Experience of working within design control processes and operating within quality systems like ISO 13485, FDA QSR or MDSAP
*Experience of interacting with engineers, test houses, internal and regulatory affairs bodies, notified bodies and audit teams
*Ability to communicate clearly and concisely at all levels of management

This is a unique chance to be involved in revolutionary medical technology on a global scale, you get an excellent package and the team you are working with offer a relaxed yet professional working environment.

Some global and UK travel may be required so you must be prepared to do this when required.

Interviews are being held next week or on receipt of suitable CV's, please contact me, Imogen, on [Removed] or email [Email Removed]







ISL (Incite Solutions Ltd) is acting as an Employment Agency in relation to this vacancy.