Regulatory Affairs Manager – Biocompatibility and Sterilization

Position Location US-CA-Rancho Santa Margarita

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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 initial device approval to post-market surveillance and design change. Our team interprets and applies regulations, standards, and guidance documents to enable Applied Medical’s devices to make a meaningful, positive difference in more than 80 countries!

The Biocompatibility and Sterility Team within the Regulatory Affairs group focuses primarily on biocompatibility and sterility of our devices. We collaborate with:

  • Engineering in the design and development process of our medical devices, which includes strategic development of test schemes and the application of risk management principles, including authorship of biological evaluations and sterilization validation protocols and reports;
  • Operations and Quality Control to complete regular bioburden and sterility audits;
  • Regulatory Affairs region specialists to establish market-specific biocompatibility test requirements and subsequent submission strategies;
  • External labs to complete testing of devices.

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. Prior to taking on direct reports, 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 Regulatory Affairs Manager of the Biocompatibility and Sterility team, 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 quality system processes and documentation and technical standards related to biocompatibility and sterilization
    • Learn the design, manufacturing process, and clinical applications of Applied Medical’s product offering
    • Collaborate with peers in RA and Engineering to ensure test requirements are met in the markets where devices are distributed
    • Author biological evaluations, sterilization validation protocols, reports, and adoptions
    • Coordinate bioburden, sterility, and biocompatibility testing with third-party labs
    • Monitor and analyze quality data for trends and indicators
  • Within a 6-12 months of joining Applied Medical:
    • Peer review technical documentation for accuracy
    • Advise team members on biological safety, sterilization principles, and test strategies
    • Answer questions from regulatory authorities and act as a subject matter expert in audits
    • Monitor the regulatory environment, including relevant domestic and international standards, regulations, and guidance documents relevant to product biocompatibility and sterility
    • Ensure ongoing compliance by implementing timely procedural updates and developing training
    • Identify, propose, and drive business process improvement projects
  • Within a 12-18 months of joining Applied Medical:
    • Participate in compliance-related decision making and strategy related to Applied Medical’s biocompatibility and sterility programs
    • Approve protocols and reports and review other quality records such as those associated with Non-Conforming Investigation Reports, Temporary Deviation Orders, and Corrective and Preventative Actions
    • Facilitate audits and inspections by regulatory agencies
    • Manage and develop Regulatory Affairs analysts and specialists

Position Requirements

This position requires the following skills and attributes:

  • Bachelor’s degree in biological or physical sciences, or engineering
  • Minimum 5 years of experience applying biocompatibility (surgically invasive and implantable) and sterilization (radiation and EO) principles
  • Minimum 3 years of experience in Regulatory Affairs or Quality Assurance in the medical device industry
  • Extensive experience effectively managing projects using 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

Preferred

The following skills and attributes are preferred:

  • Advanced education in toxicology and microbiology
  • Certification in industrial sterilization
  • Training in quality systems including QSR, ISO 13485, MDSAP

Benefits

  • 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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