Job Description

Regulatory Affairs Specialist II As a Regulatory Affairs Specialist II, you will play an essential role in ensuring compliance with regulatory requirements for medical devices throughout their lifecycle. This mid-level position involves strategic planning, regulatory submissions, and collaboration across functions 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 regulatory intelligence and related information. + Monitor the regulatory environment including specific regulations and guidance by product types and geography. + Provide information used to evaluate proposed products for regulatory classification and jurisdiction. + Research requirements, applicable guidance, and standards for regulatory submissions, approval pathways, and compliance activities. + Assist in the development of regulatory procedures and SOPs. + Collect and organize information 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 preparing dossiers 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 stakeholders. + Determine and communicate submission and approval requirements. + Assist in scheduling meetings with stakeholders and regulators and develop materials for these meetings. + Essential Skills + Experience in regulatory affairs within the medical device industry. + Proficiency in regulatory submissions, documents, and compliance. + Knowledge of FDA and EU MDR regulations. + RAC Certification is preferred. Additional Skills & Qualifications + Bachelor's or Master's degree in Regulatory Affairs, Engineering, or equivalent discipline. + 3-5 years of experience in a related role within an R&D environment. + General FDA and EU MDR knowledge. + Awareness of QMS. + Experience with post-market and change management. 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 May 23, 2025. 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. 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 [email protected] (%[email protected]) for other accommodation options.

Job Tags

Temporary work, Local area,

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