• Regulatory Affairs Specialist III – 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 Specialist III – Premarket, you will be responsible for working within the framework of a team and performing the following activities:

    • Lead regulatory strategy planning and change management in domestic and international markets
    • Manage regulatory submissions and communicate with regulatory authorities
    • Interpret and apply medical device and quality system regulations and standards in order to ensure conformance in all areas of the company
    • Collaborate with Engineering, Clinical Development and other departments to ensure regulatory requirements are met in the markets where devices are distributed
    • Facilitate audits and inspections by regulatory agencies
    • Represent Regulatory Affairs in decision-making and interdepartmental meetings related to Applied's Quality System, compliance with design controls, risk management, and domestic/international regulations
    • Seek to understand multiple pathways to compliance and incorporate all perspectives in creating solutions
    • Review/approve documentation in support of design history file and risk management file (e.g. design inputs/outputs, hazard analysis, clinical evaluation reports)
    • Review/approve other quality records such as those associated with Non-Conforming Investigation Reports, Temporary Deviation Orders, and Corrective and Preventative Actions
    • Propose, initiate, and drive business process improvement projects
    • Learn and understand changes to the regulatory environment, including relevant domestic and international standards, regulations, and guidance documents, in order to monitor and ensure conformance by implementing procedural updates and developing training
    • Mentor other team members throughout the organization through subject matter expertise and experience

    Position Requirements

    This position requires the following skills and attributes:

    • Minimum of 5+ years of experience in Regulatory Affairs or Quality Assurance in the medical device industry
    • Minimum 1 year of active experience applying design controls
    • Technical background in engineering or biological/physical sciences
    • Working knowledge of domestic and international regulations, standards and guidance documents
    • Experience reviewing and approving technical documentation
    • Ability to work independently and as part of a team
    • 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, usability and human factors
    • 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.