QA/RA Manager

CSG Talent; San Diego (CA); On-site; USD 150,000 - 170,000; Full time

Job summary

A leading medical device company is seeking a Quality and Regulatory Affairs Lead based in Southern California. The successful candidate will oversee all USA QA and regulatory functions, ensuring compliance with FDA regulations for Class II medical devices. A proven track record in Quality Assurance and Regulatory Affairs is essential. This is a full-time role with a competitive salary range of $150,000 to $170,000 plus bonuses and requires flexibility for office presentations.

Qualifications

• Proven track record in Quality Assurance and Regulatory Affairs in MedTech.
• Extensive experience with FDA management and 510(k) submissions for Class II devices.
• Ability to independently drive the QA/RA USA function.

Responsibilities

• Establish strategy for USA Regulatory and Quality Assurance activities.
• Develop and maintain relationships for FDA clearance processes.
• Oversee US Quality Management System compliance.

Skills

Quality Assurance

Regulatory Affairs

FDA submissions

CAPA

Post Market Surveillance

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

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

Sign in to set job alerts for “Quality Assurance Specialist” roles.

Quality Assurance and Compliance Specialist II

Manufacturing Quality Assurance Associate

Quality Assurance Associate I – Document Control

Call Center Quality Assurance Specialist

Junior Quality Analyst – Quality Assurance Careers (Manual Tester) (39105)

San Diego, CA $78,000.00-$92,700.00 18 hours ago

National City, CA $28.00-$36.00 11 months ago

Quality Control I/Lab (Required Flow Cytometry Exp) Entry Level - Urgent Need

Quality Assurance Specialist (Compliance Specialist)

Chula Vista, CA $28.00-$30.00 2 months ago

Manual QA / R + D - Remote Work | REF#178383

QA Manual Tester - Remote, Latin America

Tijuana, Baja California, Mexico 1 month ago

Sr Manager, Design Quality Assurance - Continuous Improvement (Hybrid)

Ship/Submarine Quality Control 1 - San Diego, CA

QA Inspector/Specialist I - Entry Level (Onsite)Exp in Life Sciences & Medical Device

Quality Control I - Must Have Flow Cytometry and Flow Exp (Urgent Need) Onsite

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