QA / RA Manager

Snr Manager - Quality and Regulatory Affairs

Salary / bonus : Up to $150,000 fixed plus bonus

Based : South California

Are you a proven quality and regulatory specialist where a fast track career move could interest you?

Would a role leading an entire N American quality and regulatory function, one that boasts a lot of opportunities for fast professional and personal growth?

CSG are proudly and exclusively partnering a global innovation leader in the acute / critical care equipment and devices space (predominantly Class II), operating in a life saving, high value and highly technical area of integrated hospital solutions.

The business is at an exciting point, growth mode and as a result are looking for an experienced Snr Quality and Regulatory Manager to join their USA Team. The business are again a global manufacturer and innovation leader, with direct manufacturing operations in the USA.

Key Responsibilities :

• Establish the strategy for all USA Regulatory and Quality Assurance activities Current account retention and growth, leading the implementation of entire USA QA / RA strategy
• The position will be involved in all phases of the complete line of products to ensure timely initial 510(k) clearance and compliance until end of the products commercial life cycle
• Will develop and maintain external relationships with key individuals and agencies that play critical roles in the FDA clearance process for all products, leading and direct high-quality, well-organized FDA submissions for new and existing products.
• Oversees all aspects of US based Quality Management System, specifically CAPA, Complaint and QMS compliance

Key Requirements :

If the above is fits your experience and approach to sales / business development please apply and I will be in touch to discuss. Just as an immediate disclaimer I can only consider people who fit the exact description above, if you apply and don't fit the specification unfortunately I will not be able to consider you.

CSG Talent are an equal opportunities employer working on behalf of the client.