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Regulatory Affairs Manager
Lake Forest, CA

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Astrix Technology Group

Regulatory Affairs Strategy Associate

Job Description

Regulatory Affairs Strategy Associate Astrix Technology Group - 3.4 Lake Forest, CA Job Details Contract $50 - $58 an hour 16 hours ago Benefits Health insurance Dental insurance Paid time off 401(k) matching Qualifications 7 years GxP Drug regulation Bachelor's degree Pharmaceutical company experience Regulatory/legal compliance standards in production Quality standards in production Collaboration with manufacturing teams Regulatory submission editing and review Biomedical regulatory compliance Senior level Standard operating procedures (SOPs) Healthcare compliance Communication skills Full Job Description Exciting development 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 Regulatory Affairs Strategy Associate Location:
Lake Forest, CA (Onsite)
Pay:
50.00-58.00
Benefits:
Medical, Dental, Holiday, PTO 401K matching
Contract:
8 month contract with extension potential Play a key role in bringing innovative ophthalmic products to market. We're looking for an experienced Regulatory Affairs professional to lead regulatory strategy and support product registrations for medical devices and pharmaceutical products. Develop and execute regulatory strategies for new and existing ophthalmic products. Manage product submissions, renewals, and regulatory approvals. Partner with manufacturing sites, regulatory agencies, and global teams to ensure compliance. Support medical device and pharmaceutical product portfolios. Maintain compliance with GxP regulations, SOPs, and quality standards. Bachelor's degree (or equivalent experience). 7+ years of Regulatory Affairs experience. Experience with medical devices and/or pharmaceuticals. Strong knowledge of regulatory submissions and global compliance. Excellent communication skills and attention to detail. Work on industry-leading eye care products. Collaborative, innovative team environment. Opportunity to make a global impact in healthcare. 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 #LI-RL1