<p>Job Title: Regulatory Affairs Specialist II</p> <p>Job Description</p> <p>A Regulatory Affairs Specialist II plays a pivotal role in ensuring that the company's medical devices comply with regulatory requirements throughout their lifecycle. This mid-level position involves a blend of strategic planning, regulatory submissions, and cross-functional collaboration to support product development and market access.</p> <p>Responsibilities</p> <ul> <li>Identify information sources and resources for local, regional, and global regulations. </li><li>Collect, organize, and maintain files on local, regional, and global regulatory intelligence and other related information. </li><li>Monitor the regulatory environment, including specific regulations, guidance, and other relevant information by product types and geography. </li><li>Provide information used to evaluate proposed products for regulatory classification and jurisdiction. </li><li>Research requirements (local, national, international), applicable guidance, standards, and options for regulatory submissions, approval pathways, and compliance activities. </li><li>Assist in the development of regulatory procedures and SOPs. </li><li>Collect and organize information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations. </li><li>Organize materials from preclinical and clinical studies for review and assist in the review process. </li><li>Compile and organize materials for pre-submission reports and communications. </li><li>Assist in the preparation of dossiers and pre-submission and submission packages for regulatory agencies. </li><li>Track the status of applications under regulatory review and provide updates to the regulatory team. </li><li>Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders. </li><li>Determine and communicate submission and approval requirements. </li><li>Assist in scheduling meetings with internal stakeholders and regulators and develop and organize materials for these meetings. </li><li>Help resolve open CAPA/NC (e.g., training, etc.). </li><li>Support end of product lifecycle (obsolescence) projects. </li><li>Support eIFU project and Ad/Promo migration. </li><li>Support RA dashboard and system integration for RA systems. </li><li>Conduct gap assessment and implement resolutions in RA QMS. </li><li>Assist in mapping procedures to identify gaps, overlaps, and alignment opportunities for integration and audit readiness. </li><li>Migrate documents into systems like Propel and SharePoint, ensuring correct formatting, metadata accuracy, and linkage to training records where applicable. </li><li>Support regulatory submissions for medical devices. </li><li>Review design changes and provide tech file support. </li></ul> <p>Essential Skills</p> <ul> <li>Proficiency in regulatory affairs, especially in medical devices. </li><li>Experience in regulatory submission, documentation, and compliance. </li><li>Knowledge of FDA and EU MDR regulations. </li><li>Strong understanding of regulatory labeling and documentation. </li><li>3-5 years of experience in a similar role within an R&D environment is preferred. </li><li>Bachelor's or Master's degree in Regulatory Affairs, Engineering, or equivalent discipline is required. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>RAC Certification is preferred. </li><li>Experience with post-market and change management is a distinct advantage. </li><li>General knowledge of QMS and awareness of quality management systems. </li></ul> <p>Work Environment</p> <p>This role requires onsite work 5 days a week in Irvine, CA. The work environment is fast-paced, requiring a self-motivated, proactive individual who can handle constantly changing priorities. The team is collaborative, and the role demands strong project management, analytical, and communication skills.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $70.00 - $80.00/hr.</p> <p>Eligibility requirements apply to some benefits and may depend on your job</p> <p>classification and length of employment. Benefits are subject to change and may be</p> <p>subject to specific elections, plan, or program terms. If eligible, the benefits</p> <p>available for this temporary role may include the following:</p> <ul> <li>Medical, dental & vision </li><li>Critical Illness, Accident, and Hospital </li><li>401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available </li><li>Life Insurance (Voluntary Life & AD&D for the employee and dependents) </li><li>Short and long-term disability </li><li>Health Spending Account (HSA) </li><li>Transportation benefits </li><li>Employee Assistance Program </li><li>Time Off/Leave (PTO, Vacation or Sick Leave) </li></ul> <p>Workplace Type</p> <p>This is a fully onsite position in Irvine,CA.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Jul 25, 2025.</p> <p>About Actalent</p> <p>Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.</p> <p>The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.</p> <p>If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.</p>