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:

• A proven track record in Quality Assurance and Regulatory Affairs across the USA in MedTech
• FDA management and 501(k) submissions experience with Class II devices
• Class II devices experience is essential, we cannot consider anyone without extensive experience in this area
• Quality Management Systems, CAPA and Post Market Surveillance experience
• The ability and experience to own and drive the entire QA/RA USA function independently
• USA citizen with the legal right to work in the USA without sponsorship
• Flexibility to regularly present in the office and manufacturing site in S California

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.