RA / QA Specialist - Medical Device 58239

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Job Description

POSITION : RA / QA Specialist – Medical Device

Job Description

POSITION : RA / QA Specialist – Medical Device

Company : A privately held medical device company based in the Carldsbad, CA area, specializing in next-generation orthopedic implants and surgical instruments, particularly for spinal procedures.

Salary Range : $100K–$110K / year (DOE), exempt position

Work Hours : M–F, 8 : 00 a.m.–4 : 30 p.m. (Flexible; some variation possible)

Work Style : On-site (No Remote / Hybrid option)

Benefits : Health, Dental, Vision, Life Insurance, 401(k), paid holidays, paid vacation, and more

Summary

This position is primarily responsible for overseeing all Regulatory and Quality Assurance functions for the company as outlined below.

Essential Duties And Responsibilities

Core duties and responsibilities include, but are not limited to, the following :

• Facilitate audits by interacting with FDA, ISO, and international regulatory bodies.
• Manage the 510(k) regulatory submission process by compiling and submitting reports and documentation to internal and external submission partners.
• Work closely with Quality and Risk Management teams to identify and mitigate risks / issues.
• File Vigilance Reports or MDRs (Medical Device Reports) to the Competent Authority or FDA.
• Coordinate across departments to prepare and facilitate submissions.
• Maintain full awareness of all regulatory activities on assigned projects, ensuring deadlines and performance standards are established and met.
• Work to minimize regulatory issues and prevent unnecessary delays.
• Evaluate changes to regulatory documents and formulate appropriate filing strategies.
• Plan, implement, and maintain the QMS.
• Conduct internal audits to ensure compliance.
• Manage quality control over the entire submission lifecycle, including component tracking, workflow execution, and issue resolution.
• Review and approve change control documents, ensuring correct filing categories.
• Represent Quality Assurance on cross-functional project teams.
• Perform other duties as assigned or required by business needs.

QUALIFICATIONS / REQUIREMENTS

Education And Experience

Experience

Computer Skills

Certificates, Licenses, Registrations

Language Skills

To apply, please send resume to itatebayashi@pasona.com

#LT-IT1

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Industries

Staffing and Recruiting

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