RA Analyst/Specialist - Premarket

US-CA-Rancho Santa Margarita

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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 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.

 

The Regulatory Affairs (RA) Analyst/Specialist will have an understanding of domestic and international Regulatory Affairs and provide support to Applied Medical's Engineering program from a Quality Management System perspective. This position is responsible for active participation in meetings, executing regulatory activities, and the review/approval of documentation associated with design controls, good manufacturing practices and medical device quality management. The role involves guiding internal teams on regulatory strategies to bring products to market as well as compliance with Applied's Quality System. The analyst and specialist roles are distinguished by level of relevant industry experience.

Position Description

As an RA Analyst/Specialist, you will be responsible for performing the following activities:

  • Understand medical device and quality system regulations and standards in order to monitor and ensure conformance in all areas of the company
  • Participate in regulatory strategy planning and change management in domestic and international markets
  • Participate in interdepartmental team meetings and contribute ideas on matters related to Applied's Quality System, compliance with design controls, risk management, and domestic/international regulations
  • Review/approve design control documentation in support of design history file (e.g. test protocols and reports for design verification, process validation)
  • Review/approve other quality records such as those associated with Non-Conforming Investigation Reports, Temporary Deviation Orders and Corrective and Preventative Actions
  • Participate and/or drive projects with competing priorities, including regulatory submissions and process improvements
  • Communicate with Engineering, Clinical Development and other departments as necessary to ensure compliance with Applied's Quality Management System 

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
  • Working knowledge of domestic and international regulations, standards and guidance documents
  • Strong writing, verbal and interpersonal communication skills
  • Technical background in engineering or biological/physical sciences
  • Demonstrated project management and organizational skills
  • Able to multi-task, prioritize and keep up with a fast-paced environment while embracing 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 holiday and vacation accrual

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