Principle Regulatory Affairs Strategy Associate

Pay Rate Low: 80.00 | Pay Rate High: 83

Exciting development Principal Regulatory Affairs Strategy Associate opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care

Principal Regulatory Affairs Strategy Associate

Location: Lake Forest, CA (Onsite)

Duration: 8-Month Contract (Potential Extension)

Benefits: Medical, Dental, Holiday, PTO 401K matching

The Principal Regulatory Affairs Strategy Associate will support regulatory strategy and compliance activities for ophthalmic products. This role partners with cross-functional teams to drive regulatory submissions, product approvals, lifecycle management, and compliance initiatives.

• Lead regulatory strategy and support for new and existing ophthalmic products.
• Manage regulatory submissions, renewals, registrations, and product changes.
• Collaborate with internal teams, regulatory agencies, and external partners to ensure timely approvals.
• Provide regulatory guidance for product development, commercialization, and lifecycle management.
• Review and support promotional materials to ensure regulatory compliance.
• Drive multiple regulatory projects and support business development and integration activities.
• Ensure compliance with applicable regulations, quality standards, and SOPs.
  
  

Qualifications

• Bachelor's degree and 7 years of Regulatory Affairs experience (or equivalent combination of education and experience).
• 5 years of leadership or project leadership experience.
• Experience supporting medical devices, pharmaceuticals, or combination products.
• Strong knowledge of regulatory submissions, compliance requirements, and product registration processes.
• Excellent communication, project management, and problem-solving skills.
  
  

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH