Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Location: Torrance, CA | Onsite

Employment Type: Temp-to-Hire

Schedule: Monday through Friday | 8:15 AM – 4:45 PM

Compensation: $40 to $43 per hour

Job Summary:

The Regulatory Affairs Specialist supports regulatory compliance activities by helping ensure products and processes meet applicable domestic and international regulatory requirements throughout the product lifecycle. This role collaborates cross-functionally with internal teams and external stakeholders to support regulatory submissions, quality system activities, validation efforts, and ongoing compliance initiatives. The position also assists with monitoring regulatory requirements, maintaining regulatory documentation and approvals, and supporting the implementation of procedures and processes aligned with quality and regulatory standards.

Key Responsibilities:

• Coordinate and prepare regulatory submission packages, technical documentation, and supporting materials for domestic and international regulatory agencies
• Support global regulatory activities by assisting with submissions, product registrations, external regulatory coordination, licenses, audits, inspections, reporting activities, and post-market regulatory requirements
• Collaborate with internal and external stakeholders to provide regulatory guidance related to product development, manufacturing, labeling, design changes, product lifecycle management, and regulatory compliance activities
• Assist in the development and execution of regulatory strategies, timelines, compliance plans, and preventive actions in alignment with evolving global regulatory requirements
• Monitor and interpret regulatory changes, industry guidance, and international requirements to support compliance and regulatory planning activities
• Review labeling, product documentation, engineering changes, contracts, and process updates to ensure accuracy, consistency, and compliance with applicable regulations and standards
• Support regulatory reporting and quality activities including investigations, CAPAs, deviations, corrective actions, recalls, and electronic submissions related to regulatory compliance
• Assist in the preparation, review, and maintenance of regulatory and quality documentation, including technical files, design history records, validation documentation, and regulatory change controls
• Help support compliance oversight activities by identifying regulatory concerns, communicating compliance requirements, and escalating issues that may impact product or regulatory standards
• Track regulatory milestones, maintain submission records, and prepare reports, summaries, and documentation to support management decision-making and regulatory activities
• Participate in project meetings, validation activities, and special assignments while exercising independent judgment to support regulatory objectives and issue resolution

Qualifications

Required:

• Bachelor’s degree in Science, Engineering, or a related field from an accredited institution, or an equivalent combination of education and experience
• Minimum of 3 years of experience within the medical device industry
• At least 1 year of Regulatory Affairs experience supporting medical device products
• Experience supporting domestic and international regulatory submissions within a regulated environment
• Experience leading regulatory submissions, recalls, e-MDR activities, or direct interactions with regulatory agencies
• Knowledge of domestic and international regulatory guidelines, submission requirements, labeling standards, and regulatory agency processes
• Knowledge of global regulatory requirements related to product registrations, product changes, labeling, and compliance activities
• Working knowledge of QSR 820, ISO 13485, IVD regulations, Design Controls, and MDSAP requirements
• Completion of regulatory coursework, seminars, trade association training, or related professional development programs
• Exposure to manufacturing, fabrication, electro-mechanical products, machining, tooling, assembly, or related production processes within a regulated industry
• Strong analytical, organizational, problem-solving, and critical thinking skills
• Excellent written, verbal, and interpersonal communication skills with the ability to collaborate across cross-functional teams
• Experience working successfully within matrixed or cross-functional environments and building collaborative internal and external relationships
• Ability to manage competing priorities, work independently, and maintain strong attention to detail in a fast-paced environment
• Proficiency with Microsoft Office and other computer-based productivity tools used for documentation, reporting, and data management

Preferred:

• Regulatory Affairs certification such as RAC (Regulatory Affairs Certification) or similar professional certification in regulatory affairs

Physical Requirements & Working Environment:

• Ability to communicate effectively both verbally and in writing with internal teams, external stakeholders, and regulatory agencies
• Ability to read, analyze, and interpret written documents, technical information, and data on a computer screen
• Ability to manage multiple priorities and respond effectively in a fast-paced work environment
• Requires prolonged periods of mental focus, visual concentration, and detailed data analysis
• Ability to sit, stand, and occasionally climb stairs throughout the workday
• Ability to occasionally lift and/or move up to 15 lbs as needed
• Occasional use of personal protective equipment may be required
• Ability to communicate effectively in person and by phone while supporting problem-solving and collaboration activities
• Occasional travel to other company or operational facilities may be required