Senior Medical Device Regulatory Affairs Lead

Medix™; Oceanside (CA); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading recruitment firm is seeking a Sr. Regulatory Affairs Specialist in Oceanside, CA. The role involves ensuring that medical device products meet global regulatory requirements. Key tasks include preparing regulatory documents and managing compliance throughout the product lifecycle. Ideal candidates will have at least 4 years of experience in Regulatory Affairs, particularly in the medical device industry, and strong skills in FDA compliance.

Qualifications

• 4 years of experience in Regulatory Affairs in the medical device industry.
• Proven experience in design control activities.
• Strong experience with U.S. product registration.

Responsibilities

• Prepare and submit domestic regulatory documents.
• Manage Technical Files and regulatory documentation.
• Lead regulatory strategies for new products.

Skills

Regulatory Affairs

U.S. FDA 510(k) writing

Attention to detail

Communication skills

Regulatory compliance

Education

College degree or equivalent in Regulatory, Quality, or R&D

Tools

ISO 13485

Job description

A leading recruitment firm is seeking a Sr. Regulatory Affairs Specialist in Oceanside, CA. The role involves ensuring that medical device products meet global regulatory requirements. Key tasks include preparing regulatory documents and managing compliance throughout the product lifecycle. Ideal candidates will have at least 4 years of experience in Regulatory Affairs, particularly in the medical device industry, and strong skills in FDA compliance.