Regulatory Affairs Specialist

Regulatory Affairs Specialist II

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.

Responsibilities :

• Identify information sources and resources for local, regional, and global regulations.
• Collect, organize, and maintain files on local, regional, and global regulatory intelligence and other related information.
• Monitor the regulatory environment, including specific regulations, guidance, and relevant information by product types and geography.
• Provide information used to evaluate proposed products for regulatory classification and jurisdiction.
• Research local, national, and international requirements, applicable guidance and standards, and options for regulatory submissions, approval pathways, and compliance activities.
• Assist in the development of regulatory procedures and SOPs.
• Collect and organize information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations.
• Organize materials from preclinical and clinical studies for review and assist in the review process.
• Compile and organize materials for pre-submission reports and communications.
• Assist in the preparation of dossiers and pre-submission and submission packages for regulatory agencies.
• Track the status of applications under regulatory review and provide updates to the regulatory team.
• Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
• Determine and communicate submission and approval requirements.
• Assist in scheduling meetings with internal stakeholders and regulators and develop and organize materials for these meetings.
• Help resolve open CAPA / NC (e.g., Training, etc.).
• Support End of Product Lifecycle (obsoletion) project.
• Support eIFU project and Ad / Promo migration aligned with procedures.
• Support RA dashboard and system integration for RA systems.
• Offset workload from RA DPO to conduct Gap assessment and conduct any resolution implementation as a result of the Gap assessment in RA QMS.
• Support assessment training and any mitigation work as part of QMS revamp work.
• Assist in mapping legacy procedures to identify gaps, overlaps, and alignment opportunities for integration and audit readiness.
• Support migrating documents into systems like Propel and SharePoint, ensuring correct formatting, metadata accuracy, and linkage to training records where applicable.
• Support regulatory submissions for medical devices.
• Review design changes.
• Provide tech file support.

Essential Skills :

Additional Skills & Qualifications :

Work Environment :

The role is onsite 5 days a week in Irvine, CA. The work environment is collaborative, with a team that enjoys working together. Employees contribute directly to improving patient outcomes and advancing healthcare through compliant and innovative medical technologies. The role supports global regulatory approvals that enable life-changing devices to reach markets.

Benefits include 3 weeks of PTO, 10 paid holidays, and standard benefits.

Job Type & Location :

This is a Contract position based out of Irvine, CA.

Pay and Benefits :

The pay range for this position is $70.00 - $80.00 / hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.

About Actalent :

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. 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.