Regulatory Affairs Associate
Company: Acro Service Corp
Location: San Diego
Posted on: February 26, 2026
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Job Description:
Job Description 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: Bachelor’s degree
required Preferred fields: Pharmacy, Biology, Chemistry,
Pharmacology, Engineering, or related scientific discipline RAC
certification preferred but not required.
Keywords: Acro Service Corp, San Diego , Regulatory Affairs Associate, Science, Research & Development , San Diego, California
