Job Description

Job Description

Position: Regulatory Affairs Specialist

Location: Irvine, CA, 92603

Duration: 18 Months contract

Pay Rate: b/w $60 - $70/hr (depending on experience)

Relocation/ Interview expenses: NO

Visa Sponsorship (H1Bs/ C2C): NO

Work Arrangement: On-site initially (5 days/week), transitioning to hybrid schedule

Position Overview

The Regulatory Affairs Specialist will be responsible for planning, coordinating, and implementing regulatory strategies for medical device products that require government approval. This role involves working closely with a global team (including Asia, Mexico, Korea, and Taiwan) and may require late afternoon calls. The position will start on-site before transitioning to a hybrid schedule.

Key Responsibilities

• Plan, coordinate, and implement regulatory strategies for products requiring government approval.
• Apply working knowledge of healthcare-related regulations to support product submissions.
• Prepare and refine submission materials, ensuring they meet regulatory requirements.
• Translate technical data into clear, reviewer-friendly content.
• Interact with regulatory bodies to facilitate approvals or clearance.
• Contribute to the strategic direction of regulatory pathway development.
• Retrieve reports and protocols from Windchill; manage transfer of licenses (over 6,000 documents) to client.
• Serve as a resource for less experienced colleagues, providing guidance and expertise.
• Work independently with minimal supervision, determining work priorities.

Qualifications

• Education: Bachelor’s Degree in Engineering (required)
• 1–2 years of regulatory experience (medical device preferred)
• Experience with submission preparation and compliance with regulatory requirements
• Familiarity with Windchill document management system (preferred)

Skills:

• Strong knowledge of healthcare regulations and industry practices
• Ability to handle both standard and non-standard regulatory situations
• Excellent organizational and documentation skills

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