Regulatory Affairs Specialist - Medical Devices/IVD Contract

Pacer Group; Martinez (CA); Sur place; USD 69 000 - 76 000; Plein temps

Résumé du poste

Pacer Group seeks a Regulatory Affairs Specialist with experience in medical devices/IVD to support global regulatory submissions, product registrations, and ongoing compliance. The role covers the U.S., EU, Canada, Latin America, APAC, and other international markets, requiring collaboration across R&D, Quality, Manufacturing, and Commercial teams.

You will maintain technical documentation, CERs, risk files, and regulatory records while supporting PMS, MDRs, CAPAs, recalls, and notified body

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 3+ years of Regulatory Affairs experience in medical devices or IVD.
• Knowledge of EU IVDR, FDA regulations, ISO 13485, ISO 14971, and MDSAP.

Responsabilités

• Prepare and manage regulatory submissions and product registrations across the U.S., EU, Canada, Latin America, APAC, and other global markets.
• Provide regulatory support for product development, labeling, risk management, change control, and commercialization.
• Maintain technical documentation, CERs, risk files, and regulatory records.
• Support PMS, vigilance, MDRs, CAPAs, complaint investigations, and recalls.
• Support audits, inspections, and notified body assessments.
• Monitor regulatory changes and conduct impact assessments.
• Collaborate with R&D, Quality, Manufacturing, and Commercial teams.

Connaissances

Regulatory Affairs

Medical Devices / IVD

Regulatory Submissions

Product Registrations

EU IVDR

FDA Regulations

ISO 13485

ISO 14971

MDSAP

Post-Market Surveillance

Regulatory Compliance

Formation

Bachelor's degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field

Outils

MasterControl

AssurX

Veeva Vault

Description du poste

Pacer Group seeks a Regulatory Affairs Specialist with experience in medical devices/IVD to support global regulatory submissions, product registrations, and ongoing compliance. The role covers the U.S., EU, Canada, Latin America, APAC, and other international markets, requiring collaboration across R&D, Quality, Manufacturing, and Commercial teams.

You will maintain technical documentation, CERs, risk files, and regulatory records while supporting PMS, MDRs, CAPAs, recalls, and notified body