Quality Assurance Regulatory Affairs Manager

Proclinical is currently recruiting for a Quality Assurance Regulatory Affairs Manager for a medical device company located in Menlo Park, CA. The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.

Job Responsibilities

• Perform QA role during various stages of product development lifecycle.
• Prepare periodic management reviews.
• Prepare and execute V&V plan and protocols.
• Assist the development team with testing and builds during various stages of product development.
• Identify potential risks before they become a problem, focusing on root cause analysis and preventive action.
• Ensure compliance with relevant standards, perform internal & external quality audits and compile detailed reports of findings.
• Participate and document design reviews.
• Manage the electronic document control system.
• Assist in regulatory filings.

Skills and Requirements:

• BS in Engineering, Sciences, or a life science related field with engineering training.
• 3+ years of experience as QA/RA specialist/engineer.
• 5+ years of experience in Regulatory Affairs activities in medical devices companies.
• Experience with ISO 13485, ISO 14971 and FDA QSR.
• Experience writing and managing SOPs.
• Medical software experience desirable.
• Must have QA experience with software products.
• Regulatory Affairs Certification.
• Experiences on AI software or medical imaging/radiology science products.
• Experiences both in US and outside.
• Clear communicator and willing to make decisions.
• Ability to juggle and prioritize multiple competing priorities and complete tasks on-time.
• Tenacious and delivery focused.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Anna Graham at (+1) 415-660-4945 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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