Hiring: Regulatory Affairs Specialist Company: Ormco Location: Brea, CA Job Posted Time: 2026-09-03 10:59:24 Employment Type: On-site Target Skills & Keywords : Microsoft Office, Regulatory Compliance About the job Experience: •2+ years of Regulatory Affairs experience in medical devices or other regulated industry. We will also consider a Master’s Degree with 1+ years of Regulatory Affairs experience in medical devices or other regulated industry. Required Skills: •Assemble and maintain CE technical files in accordance with applicable regulatory requirements. •Author, review, and approve Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR), and Post-Market Surveillance (PMS) reports. •Monitor and interpret regulatory changes, including proposed and final rules issued by global regulatory authorities, and assess their impact on company operations. •Develop and maintain procedures, standard operating procedures (SOPs), and technical documentation to support regulatory compliance and operations. •Partner cross-functionally with global registration teams to support product registrations across a diverse portfolio, ensuring alignment with country-specific requirements. •Implement and coordinate regulatory strategies and plans as directed by senior leadership, ensuring timely and compliant product registrations. •Prepare, submit, and maintain regulatory submissions, product registrations, certifications, and facility registrations for global markets. •Liaise with distributors, in-country consultants, inter-company partners, and commercial teams to fulfill regulatory requirements for product registration and compliance. Qualifications: •Bachelor's Degree •Strong working knowledge of the European Medical Device Regulation (EU MDR), including demonstrated experience with Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Post-Market Surveillance (PMS), and Periodic Safety Update Reports (PSUR). •Advanced degree or RAC certification preferred. •Master’s in Regulatory Science preferred. •Demonstrated international submissions experience (i.e., APAC, LATAM, Australia TGA, Health Canada, and/or EU Technical files a plus). •Be respectful of peers. Open-minded and willing to take an educated risk, fail fast and try again. •Demonstrated capacity to challenge the status quo and seek opportunities to set new standards. •Demonstrated capacity to take accountability of his/her work, good or bad. Takes initiative to make a positive difference and win with our customers and co-workers. •Maintains a sense of urgency and attention to detail. Must have “can do” attitude and be a team player. •Proven ability to prioritize assigned projects and manage time effectively to meet all deadlines. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!