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Company: TalentBurst, Inc.
Location: Sunnyvale
Posted on: January 24, 2023

Job Description:

Job Title: Regulatory Compliance Specialist (Compliance Specialist 3)
Location: Sunnyvale, CA 94086
Duration: 12+ Months

Skills: Working exp with FDA Audits, regulatory compliance, Audit findings, Medical device background
Lead Auditor Certificate (Proffered)

Primary Function of Position:
This position will support ISI's Internal and External Audits to ensure compliance to regulatory and statutory requirements. This person will support activities of Third-Party visits and inspections (Notified Body, FDA etc.) focusing on backroom audit support.
This individual must have knowledge of the various regulations and standards for medical devices including MDSAP (Medical Device Single Audit Program), FDA (US Food and Drug Administration) EU MDR 2017/745 (European Union Medical Device Regulation). The primary focus of this position will be FDA readiness and to ensure compliance with 21 CFR 820 quality management system regulations.
Day to day activities may include:
- Planning, practice and preparation to ensure the successful execution of external audits
- Collaboration with process owners, with the goal to provide coaching and direction for subject matter expert in order to remediate any gaps or opportunities for improvement
- Support the internal audit program by participating in an audit or preparing for site audits
- Root cause analysis investigations, planning for corrective and preventive actions related to internal audit findings or gaps identified in the quality management system
- Review and approve internal audit finding corrective action plans
- Perform gap assessments to changes in regulations or standards
- May include analysis of data or metrics to support the internal audit program
- Bachelors' degree in Engineering or the Physical or Biological Sciences
- Lead auditor certified (ISO 9001) to ISO 13485
- 5 years in a Quality, Compliance or Regulatory role in the medical device or other regulated manufacturing environment.
- Min. 3 years of experience managing quality system internal audits, providing front/backroom support for FDA inspections
- Demonstrated problem-solving, and critical thinking skills
- Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment. Strong people skills with focus on negotiation and arbitration factors.
- Ability to work remote
- Flexibility to travel - 25% (primarily Sunnyvale Headquarters and North America based manufacturing locations)

Keywords: TalentBurst, Inc., Sunnyvale , COMPLIANCE SPECIALIST 3, Other , Sunnyvale, California

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