About this opportunity
CSG Talent lists this QA/RA Manager opportunity in san diego, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
$150,000.00/yr - $170,000.00/yr
Direct message the job poster from CSG Talent
Global Headhunter - Critical Care equipment/devices & Hospital Integration/Connectivity at CSG
Quality and Regulatory Affairs Lead
Salary/bonus : Up to $170,000 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.
Seniority level
Seniority level
Entry level
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.