Regulatory Affairs Strategy Associate

Regulatory Affairs Strategy Associate

Location: Lake Forest, CA (Onsite)

Contract: 6 Months (Potential Extension)

Industry: Global Healthcare / Medical Device Company

About the Role

Our client, a leading global healthcare company, is looking for a Regulatory Affairs Strategy Associate to support regulatory activities for medical device and healthcare products. This person will help ensure products meet regulatory requirements and receive timely approvals in global markets.

Key Responsibilities:

• Support product registrations, submissions, renewals, and regulatory approvals.
• Work with regulatory agencies, manufacturing sites, and internal teams to ensure compliance.
• Help develop and execute regulatory strategies for new and existing products.
• Review regulatory documents, labeling, and product changes.
• Support medical device and/or pharmaceutical product portfolios.
• Ensure compliance with company procedures, quality standards, and regulatory requirements.
• Partner with Quality, R&D, Manufacturing, and Commercial teams on regulatory projects.

Required Qualifications :

• Bachelor's degree or equivalent experience.
• 7+ years of Regulatory Affairs experience.
• Experience with medical devices and/or pharmaceutical products.
• Knowledge of regulatory submissions, product registrations, and approvals.
• Familiarity with FDA, international regulations, or global registrations.
• Strong communication and project management skills.
• Ability to work independently in a fast-paced environment.

Preferred Qualifications

• Experience with FDA submissions, EU MDR, or global registrations.
• Knowledge of technical documentation, labeling, and change management.
• Experience supporting healthcare, medical device, or ophthalmology products is a plus.