Regulatory Affairs Specialist

🔎 Hiring: Regulatory Affairs Specialist – Medical Devices (Hybrid)

📍 Locations: San Clemente, or San Diego, CA

🕗 Work Schedule: Hybrid | 8:00 AM – 5:00 PM

We are seeking a Regulatory Affairs Specialist to provide regulatory support and expertise for U.S. and global medical device submissions. This role will support execution of global regulatory strategies, ensure compliance with FDA, EU, and international requirements, and collaborate cross-functionally to enable timely product approvals.

Key Responsibilities

• Provide regulatory support for U.S. and global submissions, including analysis of requirements and tracking deliverables
• Assist with execution of global regulatory strategies and maintenance of global registration dossiers
• Ensure regulatory compliance for submissions, change management, and product approvals (FDA, CE, and international certifications)
• Plan, prepare, and organize registration packages aligned with regional regulations and guidelines
• Support responses to regulatory agencies and notified bodies with oversight
• Partner with regional and country Regulatory Affairs teams to assess regulatory impact of product changes
• Review and approve technical and regulatory documentation; identify deficiencies and drive resolution
• Track assigned regulatory activities and manage multiple deadlines with high accuracy
• Represent Global Regulatory Affairs in R&D meetings and present regulatory positions
• Support special projects as assigned

Required Knowledge & Skills

• Strong understanding of FDA, EU, and global regulatory submission requirements
• Hands-on experience preparing regulatory submissions and securing approvals
• Experience assembling global dossiers and authoring CE technical documentation
• Solid knowledge of 21 CFR 820 and ISO 13485:2016
• Experience working directly with regulatory agencies and notified bodies
• Strong analytical skills with ability to critically assess scientific arguments
• Excellent written and verbal communication skills
• Strong problem-solving, organizational, and interpersonal skills
• Ability to balance regulatory compliance with business needs

Minimum Qualifications

• Bachelor’s degree required (pharmacy, biology, chemistry, pharmacology, engineering, or related field preferred)
• 2–4 years of Regulatory Affairs experience in the medical device industry
• Direct FDA and global submission experience required
• RAC certification preferred
• Proven project management, multitasking, and prioritization skills
• Ability to work independently with minimal supervision

💼 Why Join Us?

You’ll play a key role in advancing innovative medical devices while working with global teams in a collaborative, growth-focused environment.

📩 Interested candidates: Apply or message directly to learn more.