COMPLIANCE SPECIALIST 3
Company: TalentBurst, Inc.
Location: Sunnyvale
Posted on: January 24, 2023
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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
Requirements:
- 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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