QA / RA Manager

This range is provided by CSG Talent. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.

Base pay range

Direct message the job poster from CSG Talent

Global Headhunter - Critical Care equipment / devices & Hospital Integration / Connectivity at CSG

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.

Seniority level

Entry level

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing

Referrals increase your chances of interviewing at CSG Talent by 2x

Get notified about new Quality Assurance Specialist jobs in San Diego, CA .

Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr