Quality And Regulatory Specialist

Eastridge Workforce Solutions is partnering with a commercial medical device company in their search for a Quality & Regulatory Specialist. Our San Diego, CA client focuses on designing, developing, and commercializing innovative solutions that transform fluid management after surgical procedures. For immediate consideration for this Direct Hire role, apply today.

ESSENTIAL FUNCTIONS:

• Experience with FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.
• Review and create Certificates of Analysis (COAs)
• Analyze complaint data for trends and reportability to ensure applicable regulatory requirements are met.
• Support with NCMR, CAPA, and ASL and CAPA activities and develop a system for identifying, analyzing, preventing, and correcting quality issues.
• Assist with Quality Plan activities and the Quality Management Review process to ensure adequate reporting of quality systems metrics.
• Maintain current Quality and Regulatory knowledge of US and OUS regulations, guidelines, and standards.
• Initiate and assist with QMS SOPs, Work Instructions, Protocol, and Reports.
• Assist with external audits by Regulatory and Third-Party Auditors.
• Provides support to assure that applicable Quality and Regulatory requirements, including FDA and EU MDR regulations and standards, are incorporated in the product development and manufacturing process.
• Provide input on failure investigations on products associated with Customer Feedback and Complaints

EDUCATION/EXPERIENCE REQUIRED:

• Bachelor's degree in science or 8-10 years of equivalent work experience
• Strong written and verbal communication skills
• Expertise with Microsoft Office (Excel, Word, etc.)
• Minimum of 3-5 years of Quality and Regulatory experience in Medical Device industries
• Experience with electronic/hard copy document submissions to regulatory agencies
• Experience with UDI and GUDID
• Excellent knowledge of Microsoft Office (Outlook, Word, Excel, and PowerPoint)

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

We value diverse experiences, including prior contact with the criminal legal system, and applicants with criminal histories are encouraged to apply.Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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