Regulatory Affairs Specialist - Premarket

May 8, 2020

  

 

 

 

 

Company Name:

Applied Medical

 

Job Location:

22872 Avenida Empresa Rancho Santa Margarita, CA 92688

 

Position Title: 

Regulatory Affairs Specialist - Premarket

 

Position Type:

Full time

 

General Job Description:

 

Applied Medical is a rapidly growing, global organization that develops, manufactures and distributes medical devices to more than 75 countries. Our driving purpose is to satisfy the three fundamental healthcare needs: enhanced clinical outcomes, outstanding value and unrestricted choice. For 30 years, Applied Medical has been at the forefront of innovation and technology. As a result of our highly vertically integrated business model, we control all of our processes in-house, from R&D concept to clinical implementation. Applied Medical engineers take a hands-on approach, utilizing in-house cutting-edge technologies, such as automation and robotics, advanced metal processing, injection molding, and rapid prototyping. We invest heavily in R&D, advanced technologies and most importantly – the growth of our team members. Applied Medical is proud to have a culture firmly grounded in teamwork, collaboration and regulatory compliance, while providing opportunities for growth and choice in individual career paths. Applied Medical’s Regulatory Affairs team guides and supports the organization in maintaining compliance with regulations that govern how products are developed, tested, manufactured, and marketed. Regulatory team members have the responsibility of interpreting U.S. and international regulations, developing regulatory strategies, supporting rapid product enhancements, and utilizing customer feedback to address healthcare needs. As part of Applied Medical’s mission to bring affordable, high-quality devices to market, the Regulatory team works closely with in-house teams, as well as domestic and international customers, to distribute and sell our medical devices in more than 75 countries. The team focuses on quickly bringing new and enhanced products to patients.

 

 

 

Responsibilities:

 

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

     

 

Qualifications:

 

  • 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

     

 

Application Information & Contact (How to Apply)

 

Please apply through the  Applied Medical Careers portal with resume and cover letter

Learn more about Applied Medical here.

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