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Senior Regulatory Affairs Specialist

QA/RA | Agoura Hills, CA | Full Time

Job Description

Senior Regulatory Affairs Specialist

The Sr. Regulatory Affairs Specialist is involved with developing regulatory strategies and tactics for new and existing medical devices.  The ideal candidate would possess the skills to coordinate, maintain and provide compliance with applicable domestic and international regulatory agencies, such as the FDA. The position is on-site at our Agoura Hills location and may require additional hours and/or travel as necessary to complete time-sensitive projects.

Key Responsibilities

  • Research and provide recommendations to product teams on appropriate regulatory pathways to market

  • Participate in teams to insure appropriate global regulatory requirements are incorporated as part of the development and design change process for both new and existing products

  • Research, author or otherwise provide support for submissions and other regulatory documents to obtain approval for new or modified products into commercialization (510(k)’s, PMA Supplements, etc.)

  • Coordinate with Notified Bodies, Competent Authorities and other regulatory agencies on submissions, audits, approvals or other issues

  • Interpret existing and/or new regulatory requirements as they relate to products and procedures and communicate this to personnel

  • Provide and/or author approval of external communications materials and conduct labeling, marketing, and literature review pre and post market.

  • Research, author or otherwise provide support in preparation and updates to Technical files supporting CE Marking or other regulatory requirements

  • Interface with staff members in strategic planning, product development, operations, and customer service departments to meet priority regulatory dates

  • Assist with the development, implementation and maintenance of regulatory SOP's and development/improvement of processes and procedures

  • May also be asked to participate in RA related parts in site audits and routine RA maintenance activities. Some travel may be required

  • Participate in other duties as assigned 

Requirements:

  • Minimum 4-5 years experience in regulatory affairs within the Medical Device Industry

  • Biotechnology, engineering and/or quality/regulatory degree or current enrollment

  • Knowledge of medical device legislation US and ISO 13485/MDR corresponding guidelines

  • Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.) preferred
  • Good knowledge of product development processes in MD industry

  • Experience in the preparation, and submission of US Regulatory files (510(k)s, PMAs) is required.

  • Experience with regulatory audits and inspections

  • Microsoft Word & Excel proficiency

  • Technical report writing skills

  • Data interpretation and basic statistical analysis

  • Demonstrated attention to detail

  • Ability to work independently or in a team environment

  • Excellent written and verbal communication

  • Strong organizational and analytical skills

    • Time management skills

    • Ability to perform well in a fast-paced environment on multiple tasks