Regulatory Compliance Specialist
Company: Amick Brown, LLC
Location: Sunnyvale
Posted on: January 27, 2023
Job Description:
Amick Brown is seeking an experienced Regulatory Compliance
Specialistfor our direct client.
Location: Sunnyvale, CA
Duration: 12 Months
Estimated pay range: $46.76 - $58.46 an hour per client contract
and candidate skills, experience and work location
Description
- 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
Required Skills
- 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)
Amick Brown is an Information Technology consulting company
specializing in ERP, Data Analytics, Information Security,
Application Development, Networking, and Cloud Computing. The
company was founded in 2010 and is headquartered in San Ramon,
California.
Regular full-time employees are eligible for the following Amick
Brown provided benefits:
- Vision
- Dental
- 401k Health
- with company match
- Paid time off
- Sick Leave
- long-Term Disability
- Life Insurance
- Wellness & Discount Programs
Keywords: Amick Brown, LLC, Sunnyvale , Regulatory Compliance Specialist, Other , Sunnyvale, California
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