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 other relevant information by product types and geography.
• Provide information used to evaluate proposed products for regulatory classification and jurisdiction.
• Research requirements (local, national, international), 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 the scheduling of 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 with representative aligned to company procedures.
• Support eIFU project with representative aligned to company procedures.
• Support Ad/Promo migration of QT9 and legacy procedures.
• Support RA dashboard and system integration for RA systems.
• Offset workload from RA DPO to conduct gap assessment and resolution implementation.
• Support assessment training and mitigation work as part of QMS revamp.
• 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

• Experience in regulatory affairs with medical devices.
• Knowledge of regulatory submissions and compliance, including FDA and EU MDR.
• Proficiency in regulatory documentation and labeling.
• RAC Certification is preferred.
• Bachelor's or Master's degree in Regulatory Affairs, Engineering, or equivalent discipline.
• 3 - 5 years of experience in a similar position within an R&D environment.
• General FDA and EU MDR knowledge.
• QMS awareness/knowledge.

Additional Skills & Qualifications

• Experience with post-market and change management is a distinct advantage.
• Strong project management, analytical, and communication skills.
• Ability to work collaboratively in cross-functional teams.
• Detail-oriented and great communication skills.
• Experience in a fast-paced environment with the ability to multitask.
• Self-motivated, proactive, and able to adapt to changing priorities.

Work Environment

This position requires working onsite five days a week in Irvine, CA. The role offers 2 weeks of paid time off, 10 paid holidays, and standard benefits. Employees contribute directly to improving patient outcomes and advancing healthcare through compliant and innovative medical technologies. The work environment supports global regulatory approvals that enable life-changing devices to reach markets, with continuous learning through mentorship, cross-functional projects, and on-the-job regulatory exposure.

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. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine, CA.

Application Deadline

This position is anticipated to close on Mar 20, 2026.