Premarket Regulatory Affairs Manager

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.

The Regulatory Affairs team plays a critical role in all phases of the device lifecycle, from design, development and device approval to post-market surveillance. Our team interprets and applies regulations to enable Applied Medical’s devices to make a meaningful, positive difference in more than 80 countries! We collaborate with Engineering and Clinical Development in the design and development process of our medical devices, which includes the application of risk management principles.

Our team is expected to apply creativity and critical thinking to market implementation and regulatory submission strategies. We also play a key role in the product configuration management process. In some markets, we manage the device approval process as the license holder, and in other markets, we manage the device approval process through distributors.

The combination of Applied Medical’s mission to meet our customers’ needs and our vertically integrated business model results in rapid product evolution. This means that our Regulatory Affairs team members operate in a fast-paced, dynamic and rewarding environment.

Applied Medical’s culture prioritizes team member development, so intentional and effective leadership is crucial to cultivating an environment in which team members’ needs are met. Being a manager in the Regulatory Affairs team means that you have a thorough understanding of Applied Medical’s Quality Management System (QMS) and are responsible for identifying and creating opportunities for our team members to mature and grow professionally. Management candidates are offered a curriculum of courses and workshops designed to develop leadership, communication and management skills and to solidify their understanding of Applied Medical’s culture and business model.

We kindly ask that you submit a cover letter explaining your career interests as a supplementary document to your résumé and application.

Position Description

As Premarket Regulatory Affairs Manager, you will be responsible for being a self-starter and working in a collaborative environment to perform the duties listed below.

  • Shortly after joining Applied Medical:
    • Understand the design, manufacturing process and clinical application of one of our medical devices
    • Manage regulatory submissions and communicate with regulatory authorities and distributors
    • Collaborate with Engineering, Clinical Development and other departments to ensure regulatory requirements are met in the markets where devices are distributed
    • Contribute to regulatory strategy planning and change management in domestic and international markets, such as Asia Pacific, Latin America, the European Union, and MENA (Middle East North Africa)
    • Understand Applied Medical’s QMS and assist in compliance-related decision making related to design controls, risk management and domestic and international regulations
  • Within a few months of joining Applied Medical:
    • Mentor team members throughout the organization through subject matter expertise and experience
    • Seek to understand multiple pathways to compliance and incorporate all perspectives in creating solutions
    • Propose, initiate and drive business process improvement projects
    • Monitor the regulatory environment, including relevant domestic and international standards, regulations, and guidance documents
    • Ensure regulatory conformance by implementing procedural updates and developing training
  • Within a year of joining Applied Medical:
    • Review and approve design history and risk management file documentation (e.g., design inputs and outputs, hazard analyses, clinical evaluation reports)
    • Review and approve other quality records such as those associated with Non-Conforming Investigation Reports, Temporary Deviation Orders, and Corrective and Preventative Actions
    • Manage team members who have a variety of product or regional specialties
    • Facilitate audits and inspections by regulatory agencies
    • Interpret and apply medical device and quality system regulations and standards to ensure conformance in all areas of the company

Position Requirements

This position requires the following skills and attributes:

  • Minimum 3 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 or physical sciences
  • Extensive experience effectively managing projects and developing advanced organizational skills
  • Ability to multitask and prioritize projects that align with departmental and organizational objectives
  • Working knowledge of domestic and international regulations, standards and guidance documents
  • Experience in reviewing and approving technical documentation
  • Strong writing, verbal and interpersonal communication skills
  • Ability to work independently and as part of a team
  • Assertive and not afraid to ask questions
  • Strategic-minded, analytical and detail-oriented


The following skills and attributes are preferred:

  • Training in quality systems including QSR, ISO and CE marking, usability, and human factors
  • Experience with mechanical and electrical medical devices 


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


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