• Regulatory Affairs Analyst

    Position Location US-CA-Rancho Santa Margarita
  • _________________________________________________________________________________


    Applied Medical is a new generation medical device company with a proven business model and commitment to innovation that has fueled our rapid business growth and expansion. Applied Medical has been developing and manufacturing advanced surgical technologies for over 30 years, and has earned a strong reputation in healthcare.  Our dedication to delivering the highest quality products and unique business positioning, provides our team members with the unique ability to contribute in a larger capacity than is possible in typical positions.

    Position Description

    As a Regulatory Affairs Analyst you will be responsible for working within the framework of a team and performing the following activities:

    • Participate in change management with respect to device and facility registration in domestic and international markets
    • Contribute to regulatory submission packets and support registration and importation activities
    • Author and review regulatory and technical file documentation
    • Collaborate with Engineering, Clinical Development and other departments as necessary to ensure regulatory requirements are met in the markets where devices are distributed
    • Understand medical device and quality system regulations and standards in order to monitor and ensure conformance
    • Participate in interdepartmental team meetings and contribute ideas on matters related to Applied's Quality System, compliance with design controls and cGMP, risk management, and domestic/international regulations
    • Seek to understand multiple pathways to compliance and incorporate all perspectives in creating solutions
    • Participate in and contribute to projects with competing priorities, including business process improvements

    Position Requirements

    This position requires the following skills and attributes:

    • Minimum of 1+ years of experience in Regulatory Affairs or Quality Assurance in the medical device industry or equivalent work experience
    • Familiarity with domestic and international regulations, standards and guidance documents
    • Strong writing, verbal and interpersonal communication skills
    • Demonstrated project management and organizational skills
    • Ability to multi-task and prioritize projects to align with department and organizational objectives
    • Keep up with a fast-paced environment
    • Positive attitude and embraces constructive change
    • Assertive, not afraid to ask questions
    • Strategic minded, analytical and detail oriented
    • Must be proficient with computers (Microsoft Office Suite, Adobe Acrobat), copiers and general office equipment


    The following skills and attributes are preferred:

    • Training in Quality Systems including QSR, ISO/CE marking
    • Experience with mechanical and electrical medical devices 
    • Technical background in engineering or biological/physical sciences
    • Additional language skills (Japanese, Spanish, Portuguese, Mandarin, Arabic)


    • Training and mentorship with ongoing learning and development courses
    • On-campus wellness activities
    • Comprehensive medical and dental coverage
    • Education reimbursement program
    • 401(k) program with employer match
    • Generous vacation accrual and paid holiday schedule


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