Stephana Biggins Email & Phone Number | Quality Assurance and Regulatory Affairs professional in Medical Device and Pharmaceutical Drug industries. Proven track record of executing quality and regulatory projects to ensure compliance with the FDA, ISO 13485/9001, EU MDR, and other applicable agencies. Expertise: FDA Drug Regulations FDA Medical Device Regulations Establishment Registrations and Listings Unique Device Identifier (UDI) 21 CFR 820 Quality Systems EU MDR 2017/745 Medical Device Regulations ISO 13485/9001 Quality Management Systems ISO 14644 Cleanrooms and Controlled Environments ISO 19011 Guidelines for Auditing Quality Management Systems ISO 11134 Sterilization of Healthcare Products (Gamma) Supplier Qualification and Auditing QMS Auditing Corrective and Preventive Actions (CAPA) 510(k) Prop 65 RoHS Requirements

Stephana Biggins

Quality Assurance and Regulatory Affairs professional in Medical Device and Pharmaceutical Drug indu...
Metro Jacksonville, Metro Jacksonville, United States

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Stephana Biggins’s Email stephana.biggins@jnjmedicaldevices.com

Stephana Biggins’s Phone Numbers

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Stephana Biggins’s Location Metro Jacksonville, Metro Jacksonville, United States

Stephana Biggins’s Current Industry Johnson And Johnson Vision

Stephana Biggins’s Prior Industry Johnson And Johnson Vision Care | Gforce Life Sciences Consulting | Mckesson Medical Surgical | Microtek Medical | Biomet

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Work Experience

Johnson And Johnson Vision

Principal Compliance Engineer, External Manufacturing

2021-07-01 00:00:00 - Present

Johnson And Johnson Vision Care

Staff Compliance Specialist

2017-05-01 00:00:00 - 2021-07-01 00:00:00

Gforce Life Sciences Consulting

Senior Quality Assurance Consultant

2016-11-01 00:00:00 - 2017-05-01 00:00:00

Mckesson Medical Surgical

Quality Assurance Regulatory Affairs Manager

2010-03-01 00:00:00 - 2016-04-01 00:00:00

Microtek Medical

Sterilization Validation Supervisor

2009-07-01 00:00:00 - 2010-02-01 00:00:00

Biomet

Regulatory Compliance Specialist

2002-06-01 00:00:00 - 2009-07-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Stephana Biggins

Stephana Biggins is located at
Metro Jacksonville, Metro Jacksonville, United States

Stephana Biggins is a Quality Assurance and Regulatory Affairs professional in Medical Device and Pharmaceutical Drug industries. Proven track record of executing quality and regulatory projects to ensure compliance with the FDA, ISO 13485/9001, EU MDR, and other applicable agencies. Expertise: FDA Drug Regulations FDA Medical Device Regulations Establishment Registrations and Listings Unique Device Identifier (UDI) 21 CFR 820 Quality Systems EU MDR 2017/745 Medical Device Regulations ISO 13485/9001 Quality Management Systems ISO 14644 Cleanrooms and Controlled Environments ISO 19011 Guidelines for Auditing Quality Management Systems ISO 11134 Sterilization of Healthcare Products (Gamma) Supplier Qualification and Auditing QMS Auditing Corrective and Preventive Actions (CAPA) 510(k) Prop 65 RoHS Requirements

Stephana Biggins currently works in the Johnson And Johnson Vision |

No Languages Available

Stephana Biggins has prior
experience in the following industries:
Johnson And Johnson Vision Care | Gforce Life Sciences Consulting | Mckesson Medical Surgical | Microtek Medical | Biomet

Stephana Biggins has the following professional experience:
Johnson And Johnson Vision | Johnson And Johnson Vision Care | Gforce Life Sciences Consulting | Mckesson Medical Surgical | Microtek Medical | Biomet