Regulatory Affairs Analyst - Laboratory Testing

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 nearly 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 – Laboratory Testing, you will be responsible for working within the framework of a team and performing the following activities:

  • Coordinate all testing activities for bioburden, sterility, biocompatibility or other testing programs requiring outside services from a third-party laboratory. Testing will include both routine audits as well as R&D projects
  • Ensure all quarterly, semi-annual, or other regularly scheduled audits are conducted on time
  • Write protocols and final test reports
  • Participate in the analysis and trending of laboratory data
  • Coordinate purchase orders related to laboratory testing
  • Work with team members from engineering and production to collect and send samples for testing
  • Learn and understand the standards and requirements associated with sterilization and biocompatibility
  • Ensure compliance with relevant standards, regulations, and guidance documents
  • Procure standards and ensure these documents are available to Applied team members by maintaining a database
  • Facilitate the gap analysis process by performing gap analyses
  • Contribute ideas and participate in projects to improve efficiency and costs of laboratory tests, while maintaining quality

Position Requirements

This position requires the following skills and attributes:

  • Minimum of 1+ years of work experience in a relevant industry
  • Ability to work independently and as part of a team
  • Positive attitude and embraces constructive change
  • Customer service oriented
  • Ability to multi-task and prioritize projects to align with department and organizational objectives
  • Assertive, not afraid to ask questions
  • Detail oriented, organized, and able to manage testing projects in a fast-paced environment
  • Effective writing, verbal and interpersonal communication skills
  • Must be familiar with computers (Microsoft Office Suite, Adobe Acrobat), copiers and general office equipment

 

Preferred

The following skills and attributes are preferred:

  • College degree
  • Technical background in biological/physical sciences
  • Experience with 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

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