Location
San Clemente, CA and San Diego, CA
Position Description Regulatory Affairs Associate II responsible for providing regulatory support for U.S. and global medical device submissions. The role supports execution of global regulatory strategies, preparation and maintenance of registration dossiers, and ensures regulatory compliance for product approvals and change management activities. The associate works cross-functionally with R&D and regional regulatory teams and supports interactions with regulatory authorities and notified bodies under supervision.
Skills Required
Strong knowledge of FDA, EU MDR, and global regulatory submission requirements
Experience preparing FDA submissions and CE technical documentation
Experience preparing Technical Files / Technical Documentation
Experience with 510(k) and ISO 13485
Understanding of 21 CFR 820 and ISO 13485:2016
Ability to assemble and maintain global regulatory dossiers
Strong documentation review and technical writing skills
Critical thinking and scientific assessment capability
Strong organizational and project-tracking skills
Effective written and verbal communication
Ability to manage multiple deadlines and priorities
Experience Required
2–4 years of Regulatory Affairs experience in the medical device industry
Hands-on experience with FDA and international regulatory submissions
Experience authoring or supporting CE Technical Files
Exposure to working with regulatory agencies or notified bodies preferred
Education Required
Preferred fields: Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or related scientific discipline
RAC certification preferred but not required.
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Position Description Regulatory Affairs Associate II responsible for providing regulatory support for U.S. and global medical device submissions. The role supports execution of global regulatory strategies, preparation and maintenance of registration dossiers, and ensures regulatory compliance for product approvals and change management activities. The associate works cross-functionally with R&D and regional regulatory teams and supports interactions with regulatory authorities and notified bodies under supervision.
Skills Required
Strong knowledge of FDA, EU MDR, and global regulatory submission requirements
Experience preparing FDA submissions and CE technical documentation
Experience preparing Technical Files / Technical Documentation
Experience with 510(k) and ISO 13485
Understanding of 21 CFR 820 and ISO 13485:2016
Ability to assemble and maintain global regulatory dossiers
Strong documentation review and technical writing skills
Critical thinking and scientific assessment capability
Strong organizational and project-tracking skills
Effective written and verbal communication
Ability to manage multiple deadlines and priorities
Experience Required
2–4 years of Regulatory Affairs experience in the medical device industry
Hands-on experience with FDA and international regulatory submissions
Experience authoring or supporting CE Technical Files
Exposure to working with regulatory agencies or notified bodies preferred
Education Required
Preferred fields: Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or related scientific discipline
RAC certification preferred but not required.
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