Regulatory Affairs Specialist – Premarket


Position: Regulatory Affairs Specialist - Premarket

Location: Rancho Santa Margarita, CA

Posted: July 9, 2020

Location: 22872 Avenida Empresa, Rancho Santa Margarita, CA
Job Type: Full-time
Contact Name: Megan Schneider
Phone: 949-713-8315

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.

If you are interested in joining Applied Medical and meet the position requirements, please apply online at Resumes without accompanying cover letters will not be considered.

Job Description:

As a Regulatory Affairs Specialist – Premarket, you will be responsible for working in a collaborative environment and performing the following activities:

  • 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
  • Review/approve other quality records such as those associated with Non-Conforming Investigation Reports, Temporary Deviation Orders, and Corrective and Preventative Actions
  • Lead 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)
  • Manage regulatory submissions and communicate with regulatory authorities
  • Collaborate with Engineering, Clinical Development and other departments to ensure regulatory requirements are met in the markets where devices are distributed
  • Seek to understand multiple pathways to compliance and incorporate all perspectives in creating solutions
  • Facilitate audits and inspections by regulatory agencies
  • Review/approve documentation in support of design history file and risk management file (e.g. design inputs/outputs, hazard analysis, clinical evaluation reports)
  • Mentor other team members throughout the organization through subject matter expertise and experience
  • 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, to monitor and ensure conformance by implementing procedural updates and developing training
  • Interpret and apply medical device and quality system regulations and standards to ensure conformance in all areas of the company

Job Requirements:

  • Minimum of 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/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

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