Regulatory Affairs Specialist — Medical Devices

ConsultNet Technology Services and Solutions; Irvine (CA); In loco; USD 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

ConsultNet Technology Services and Solutions is seeking a Jr. Regulatory Affairs Specialist to support product development teams with regulatory inputs, strategies, reports and design control deliverables.

The role involves preparing QA/Regulatory reports, supporting regulatory submissions, and conducting research to determine regulatory requirements across markets. Experience with audits, material controls, and regulatory agencies is advantageous.

Competenze

• Must understand 21 CFR Quality System Regulations/cGMPs and ISO 13485 Quality System Standard.
• Knowledge and experience with Medical Device Single Audit Program (MDSAP) and EU/UK medical device regulations a plus.
• Ability to write regulatory strategies and supporting documentation/reports.
• Experience preparing and supporting deliverables for 510K and CE Marking submission documents.

Mansioni

• Support product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables.
• Prepare QA/Regulatory reports and present status in review meetings.
• Prepare and support deliverables for Regulatory Agency submissions or in support of customer QARA needs.
• Perform research to determine Regulatory requirements of product markets & product requirements.
• Support internal, agency and customer audits and any resulting nonconformity/improvement actions.
• Maintain and support material controls and deliverables to meet RoHS, REACH, Prop 65, and other applicable material controls.
• Support/fulfill requirements related to CAFDB, USFDA, EU MDR, UK MDR, Health Canada, OSHA, DTSC, OC Health, and other regulating agencies.
• Maintain current procedures. Prepare and support deliverables for 510K and CE Marking submission documents and maintain records.

Conoscenze

Regulatory affairs

Medical devices

Quality systems

Technical writing

Data analysis

Microsoft Word

Excel

Access

ERP systems

Formazione

Bachelor of Science

Strumenti

Microsoft Word

Excel

Access

ERP systems

Descrizione del lavoro

ConsultNet Technology Services and Solutions is seeking a Jr. Regulatory Affairs Specialist to support product development teams with regulatory inputs, strategies, reports and design control deliverables.

The role involves preparing QA/Regulatory reports, supporting regulatory submissions, and conducting research to determine regulatory requirements across markets. Experience with audits, material controls, and regulatory agencies is advantageous.