Job Description

Join Kelly FSP as a Senior Regulatory Compliance Analyst at our client site in Irvine, CA!

This is a hybrid opportunity on site Tuesday/Thursday and as needed for audits

QUALIFICATIONS:

Minimum education required:

A Bachelor’s degree is required, preferably in a science or technical discipline.

• At least 5 years of experience in a Quality, Manufacturing or Engineering function in medical device industry
• At least 5 years of experience in a Quality, Manufacturing or Engineering function in medical device industry
• Experience with MDSAP Audits, health authorities and notified bodies
• Working knowledge of medical device regulations and standards: 21 CFR Part 820 QSR, ISO 13485, Brazil GMP, Canada Medical Devices Regulations SOR 98-282, Japan’s MHLW MO 169, EU MDR 2017/745
• Lead Auditor certification from an accredited / recognized organization (preferred)
• Project management experience (preferred)
• Certifications: Green Belt/Process Excellence, CMMI Lead Assessor, or other Quality Certifications (preferred)
• Supervisor experience, talent development (preferred)
• Strong written and oral communication skills as well as report writing, presentation and training skills
• Proven leadership, teamwork, collaboration, and influencing skills to drive the right actions and enable adoption of best practices
• Capability to interpret regulatory requirements in the light of current trends and business application
• Ability to accomplish objectives in a timely manner with limited or without day-to-day supervision.
• Good interpersonal skills; customer oriented
• Demonstrated initiative and assertiveness
• Strong problem solving and root cause analysis skills
• Look for pragmatic solutions that balance risk/benefit for both short- and long-term success
• Be open to diverse opinions and ideas. Active listening
• Strong computer skills and use of software application(s), including MS Windows, MS Office (Word, Excel, PowerPoint)

JOB GOAL:

Conducts audits - planned and not planned - to verify the compliance with the government regulations and applicable standards, along with the company policies and procedures. Provides guidance or advice to the organization concerning the compliance as required.

RESPONSIBILITIES:

• Assures that Quality System Audits comply with QSR/GMP and ISO requirements.
• Conducts internal audits of the Quality System in order to verify the compliance with the government regulations and applicable standards along with the company policies and procedures. Conducts audits of good laboratory practices (GLP) as required.
• Provides guidance or advice regarding the compliance with applicable standards and regulations
• Conducts re-audits to deficient aspects and to implemented corrective/preventive actions as needed and required.
• Assigns classifications to internal audit observations and document the audit results in written reports that are distributed and reviewed by the appropriate management.
• Monitors the effectiveness of the corrective actions documented on the observation responses.
• May be lead auditor of auditors’ team, technical experts, trainee auditors, and/or volunteer auditors.
• Reviews appropriateness of responses to audit observations, also, acts as consultant of other areas that are not audited by him/her, providing advice on audit observations response.
• Maintains the audit reports files, re-audits files and the responses to the audits performed.
• Escort to external auditors, government agencies representatives or those required by management during the execution of the audit as applicable.
• Conducts audits to other sites as required per the management.
• Complies and review metrics related to Compliance and communicate them to the site management and Franchise. Prepares information for the Management Review meetings.
• Participates in the formulation of Policies and Regulatory Procedures in compliance with the standards and applicable local, state and federal regulations through the development of Franchise Documents.
• Keeps updated on government regulations and applicable standards changes through publications, participation in seminaries or collaboration with organizations.
• Responsible for communicating business related issues or opportunities to next management level
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

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