• Regulatory Affairs Analyst – Premarket

    Position Location US-CA-Rancho Santa Margarita
  • _________________________________________________________________________________

    Applied-Medical-Logo-w-Tag_H_Teal_cropped

    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 - Premarket 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 communicate with regulatory authorities
    • 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
    • Review documentation in support of design history file (e.g. biocompatibility, labeling, sterilization)
    • 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
    • Technical background in engineering or biological/physical sciences
    • 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

    Preferred

    The following skills and attributes are preferred:

    • Training in Quality Systems including QSR, ISO/CE marking
    • Experience with mechanical and electrical medical devices 

    Benefits

    • 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

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Need help finding the right position?

    We can recommend positions specifically for you! Click here to get started.