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Principal Regulatory Affairs Strategy Associate

Astrix

Pay Rate Low: 80.00 | Pay Rate High: 83 Principal Regulatory Affairs Strategy Associate Exciting development 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. 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. Responsibilities 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! #J-18808-Ljbffr Astrix

Vacancy posted 6 hours ago
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