Regulatory Affairs Specialist - 205417

Medix™; Carlsbad (CA); Hybrid; USD 48,216 - 49,593; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to join their dynamic team in Carlsbad. This role offers an exciting opportunity to support international regulatory submissions for medical devices across multiple markets. You will work closely with cross-functional teams, ensuring compliance and timely filings while managing communications with distributors. This temporary position is perfect for someone with a strong background in regulatory affairs and a passion for the medical equipment industry. If you're ready to make a significant impact in a collaborative environment, this is the role for you!

Qualifications

• 2–4 years of experience in Regulatory Affairs for international markets.
• Strong knowledge of medical device regulations and compliance.

Responsibilities

• Support international regulatory submissions for various markets.
• Coordinate with consultants to gather requirements and prepare documentation.
• Collaborate with teams on product changes and compliance.

Skills

Regulatory Affairs Experience

Knowledge of International Medical Device Regulations

Organizational Skills

Communication Skills

Job description

Job Title: Regulatory Affairs Specialist

Location: Carlsbad, CA

Pay Range: $35.00/hr - $36.00/hr (based on skills and experience)

Shift: M-F, Business Hours (Hybrid schedule: 3 days on-site / 2 days remote)

Duration: 4 months+

Qualifications:

• 2–4 years of Regulatory Affairs experience supporting international markets
• Strong knowledge of international medical device regulations
• Ability to work independently, manage multiple submissions, and adapt quickly
• Excellent organizational and communication skills for global teamwork

Responsibilities:

• Support international regulatory submissions and renewals for markets including Mexico, Colombia, Saudi Arabia, Chile, and Japan
• Coordinate with international consultants and distributors to gather requirements, prepare documentation, and submit registration files
• Collaborate with Marketing and Engineering teams on product changes, line extensions, and compliance
• Track ongoing projects and ensure timely regulatory filings
• Serve as the main contact for distributor requests and manage communications proactively

Additional Details:

• Seniority Level: Associate
• Employment Type: Temporary
• Job Functions: Quality Assurance, Manufacturing, Engineering
• Industry: Medical Equipment Manufacturing

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