Regulatory affairs specialist

Pacer Group; Martinez (CA); Vor Ort; USD 69.000 - 76.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory Affairs

Medical Devices / IVD

Regulatory Submissions

Product Registrations

EU IVDR

FDA Regulations

ISO 13485

ISO 14971

MDSAP

Post-Market Surveillance

Regulatory Compliance

Ausbildung

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

Tools

MasterControl

AssurX

Veeva Vault

Jobbeschreibung

Job Title: Regulatory Affairs Specialist

Location: Pacheco, CA 94553

Duration: 12–18 Months

Schedule: Standard Shift

Work Arrangement: Onsite

Nature of Job: Contract

Pay Rate: $50–$55/hr.

Job Type: Contract

Domain: Regulatory Affairs / Medical Devices & IVD

Deadline: 10/23/2026

Position overview

We are seeking a Regulatory Affairs Specialist with experience in medical devices/IVD to support global regulatory submissions, product registrations, compliance, and post-market activities.

The Regulatory Affairs Specialist will support regulatory activities across multiple global markets, including the U.S., EU, Canada, Latin America, APAC, and other international markets. This role will work closely with R&D, Quality, Manufacturing, and Commercial teams to support product development, regulatory compliance, commercialization, and post-market requirements.

Skills required

Primary skills

• Regulatory Affairs
• Medical Devices / IVD
• Regulatory Submissions
• Product Registrations
• EU IVDR
• FDA Regulations
• ISO 13485
• ISO 14971
• MDSAP
• Post-Market Surveillance (PMS)
• Regulatory Compliance

Secondary skills

• Technical Documentation
• Clinical Evaluation Reports (CERs)
• Change Control
• MDRs
• CAPAs
• Complaint Investigations
• Recalls
• Regulatory Audits and Inspections
• Notified Body Assessments
• eQMS Systems
• MasterControl
• AssurX
• Antibody-Based Diagnostics

Major job responsibilities

• 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.

Required qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, 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.
• Experience with international submissions and registrations preferred.

Preferred skills

• Experience with international regulatory submissions and product registrations.
• Experience with antibody-based diagnostics.
• Experience working with eQMS systems such as MasterControl, AssurX, or Veeva Vault.
• RAC certification preferred.

AI usage policy

AI tools may be used to assist with candidate screening and administrative processes. Final hiring decisions are made by human recruiters and hiring managers.

EEOC compliance

We are an equal opportunity employer and consider qualified candidates without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under applicable law.