QA & RA Manager

This role is a great opportunity to take ownership of the QA/RA scope in the business, working closely with the directors to deliver FDA approval on a novel medical device over the next 6-12 months. Working for a small growing business will give you the autonomy and ownership of the role – delivering the project is critical to their scope and growth plans globally so it’s critical the person taking up the position is driven to succeed and committed to the overal vision of the business and product.

Zenopa are really pleased to be partnered with a growing UK subsidary of a highly innovative, global, public listed company with over 30 years experience develop novel plasma focused products. This innovative company is the leader in treatment of chronic wounds through the use of cold plasma – they develop and manufacture their devices in the UK and are committed to the highest quality of product and service to their customers.

KEY COMPETENCIES REQUIRED:
Drive to succeed
Flexibility and Resilience
Quality objectives
Initiative
Attention to Detail
Communication, impact & influence

Person Spec:
University degree in relevant life science, scientific or engineering-based discipline

Skills:
– IT skills, MS Office, Internet & email
– Language skills – Fluent in writen & spoken English

Knowledge & Experience
– A minimum of 4 years working in an MDD/MDR /FDA Regulatory/ISO13485 environment
– Good understanding of EU MDD/MDR,FDA, ISO 13485 requirements and ability to communicate and provide training on these technical and regulatory documents
– Internal Auditor
– Experience of FDA submissions

Competitive salary
plus bi-annual profit-sharing bonus
– 4 day working week (34 hours) with fully flexible working hours
– private pension
– private health insurance