Senior Analyst, Regulatory Affairs
Location:
Irvine , California
Posted:
April 02, 2017
Reference:
4463161219-en-us

The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Senior Analyst, Regulatory Affairs, aligned to Acclarent, located in Irvine, CA.
 
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
 
 
The Senior Analyst, Regulatory Affairs, provides timely and accurate regulatory affairs support to project teams working to realize new and modified product designs in accordance with company policies and procedures. 

The incumbent may perform any combination of the following activities with minimal direction:
  • Prepare FDA domestic and international submissions for new products and product changes as required to ensure timely approval for market release.
  • Prepare and execute regulatory strategies/plans.  Provide ongoing support to product development teams for regulatory issues/questions.
  • Provide support to new and currently marketed products, as necessary, including reviewing product labelling and preparing product changes notices and associated documentation for changes requiring regulatory approval.
  • Prepare, submit and review engineering and document change notices, as required.
  • Maintain registration and listing database for Acclarent for FDA-regulated products.
  • Ensure regulatory affairs product files are appropriately maintained to support compliance with regulatory requirements.
  • As required, assist RA/QA teams during inspections by Notified Bodies and Competent Authorities.
  • Provide support to regulatory meetings with Regulatory Agencies Competent Authorities.
  • As time permits, support clinical department by assisting with clinical protocols, case report forms, patient informed consent, IRB submissions, clinical database, clinical reports and case support.
  • At the direction of the Manager, Regulatory Affairs, perform training on regulatory-related matters with Acclarent personnel.
  • Other responsibilities as required or assigned by manager.

Qualifications
  • Bachelor’s degree with at least 4 years of professional experience in the medical device industry is required
  • Thorough knowledge of FDA and international regulations pertaining to the design, manufacture and commercialization of medical devices is required
  • Demonstrated proficiency with worldwide regulatory planning/strategy and submission planning/preparation is required
  • Proven proficiency with PC-based productivity applications, including Microsoft Word, Excel, PowerPoint and Project is required
  • Experience in project team participation and domestic submissions is required
  • Strong regulatory and clinical writing skills required
  • Demonstrated ability to analyze complex regulations and guidance documents is required
  • Advanced degree in a related field is preferred
  • A basic understanding of sinus disease and treatments is preferred
 
This position is located in Irvine, CA and may require up to 10% travel.
 
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
 

Primary Location
United States-California-Irvine
Organization
Acclarent, Inc. (6206)
Job Function
Regulatory Affairs
Requisition ID
4463161219

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