Janet MacOnes Email & Phone Number
Regulatory Affairs Compliance Manager @ SteriCare Solutions
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Janet MacOnes Location
- United States
Janet MacOnes Work
- 2025 -now Regulatory Affairs Compliance Manager @
- 2021 -now Consultant RAQA @ Macones
- 2024 -2025 Regulatory Affairs Manager @
- 2020 -2024 SR. RAQA @
- 2020 -2023 VP Risk Management and Policy @
- 2018 -2021 Senior Quality Assurance Regulatory Affairs @
- 2017 -2019 Senior RA QA @
- 2009 -2018 Sr. Regulatory Affairs Quality Assurance @
- 2009 -2011 Regulatory Affairs QMS Specialist (International) @
- 2011 -2013 Global Regulatory Compliance Specialist @
- 2008 -2009 Quality Compliance Consultant @
Janet MacOnes Education
- BSI British Standards Institution
ISO 13485:2016 Lead Auditor (TPECS) (MD- Medical Device Management Systems v1.1 AU- Management Systems Auditing v2.0 TL- Leading Management Systems Audit Teams v2.0)
- BSI
ISO 19011:2018 (Auditing Management Systems)
- Advisera
ISO 21001 Foundations Information Technology Security (ISO IEC 27000-2014 Information Technology Security)
2020 - NSF International Public Health and Safety Organization
(EU US MDR and MDSAP Requirements)
2020 - Ohlone College
(English Language and Literature, General Graphic Design, Marketing)
- Silicon Valley College
Graphic Design, Desktop Publising (Graphic Design, Desktop Publising)
Janet MacOnes Skills
- Technical Files
- Remediation
- ISO 14971
- External Audits
- TrackWise
- Root Cause Analysis
- Process Validation
- Part 820
- Microsoft Excel
- Quality Auditing
- Leadership
- Regulatory Affairs
- Training
- Quality Assurance
- Medical Devices
- CAPA
- Project Management
- Complaint Investigations
- Compliance
- MDRs
- IVDD
- IVD
- Consulting
- Design Control
- FDA
- CE marking
- ISO 13485
- Sop
- Validation
- Change Control
- GMP
- Quality System
- Biotechnology
- Cross-functional Team Leadership
- Pharmaceutical Industry
- V&V
- R&D
- Regulatory Submissions
- Management
- Life Sciences
- U.S. Food and Drug Administration (FDA)
- Research and Development (R&D)
- Verification and Validation (V&V)
- Standard Operating Procedure (SOP)
- Corrective and Preventive Action (CAPA)
- MDR
- tech file
- Internal Audit
- Regulatory Compliance
- Standards Compliance
- European Union
- MDSAP
- Cross Functional Team
- Verification and Validation V&V
- Regulatory
- Corrective and Preventive Action Capa
- SAN
- Research and Development R&d
- Cross Functional Team Leadership
- u.s. Food and Drug Administration Fda
- Standard Operating Procedure Sop
- Research and Development
- Standard Operating Procedure
- u.s. Food and Drug Administration
- Verification and Validation
- Corrective and Preventive Action
Janet MacOnes Summary
- Janet MacOnes, based in United States, is currently a Regulatory Affairs Compliance Manager at SteriCare Solutions. Janet MacOnes brings experience from previous roles at Macones, Ferris Mfg. Corp., RQM+ and SolonTek Corporation. Janet MacOnes holds a ISO 13485:2016 Lead Auditor (TPECS) in MD- Medical Device Management Systems v1.1 AU- Management Systems Auditing v2.0 TL- Leading Management Systems Audit Teams v2.0 @ BSI British Standards Institution. With a robust skill set that includes Technical Files, Remediation, ISO 14971, External Audits, TrackWise and more. Janet MacOnes has 3 emails and 1 mobile phone numbers on RocketReach.
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