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Senior Regulatory Affairs Program Lead

Company Name: Johnson & Johnson
Location: Irvine, CA
Job Type: Full-tim
Contact Name: Human Resources
Phone: n/a
Email: n/a
Salary: DOE

Job Description

The one CSS Group of Companies is recruiting for a Senior Regulatory Affairs Program Lead to be in Irvine, California.

ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit or follow us at

You will provide administrative and technical support to Regulatory Affairs leadership in order to facilitate compliance with applicable FDA (Food & Drug Administration) and other U.S. and international regulatory requirements.

  • Writes, coordinates, compiles, and submits Regulatory documents to FDA and global Regulatory Agencies, including EPA, International Authorities, and Notified Bodies. Includes the preparation of various international documents, including European, Australian, and Russian Technical Files.
  • Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products.
  • Creates detailed Regulatory assessments and plans for new or modified products.
  • In-depth team engagement and participation, including Core Team membership for complex projects.
  • Evaluates proposed product modifications for Regulatory impact on a world-wide basis.
  • Reviews and approves promotional items and product labeling to ensure compliance with Regulatory requirements.
  • Provides Regulatory guidance and support to life-cycle management and new product development teams.
  • Ensures compliance with regulatory agency regulations and interpretations.
  • Ensures preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
  • Prepares responses to regulatory agencies' questions and other correspondence.
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
  • Develops timelines for submissions under the direction of Regulatory Affairs leadership.
  • Provides solutions to acute complex problems.
  • Provides regulatory advice to various project teams.

Job Requirements 

  • A minimum of a Bachelor's degree is required; scientific discipline preferred.
  • A minimum of 6-8 years related work experience (Regulatory Affairs or Quality Systems required).
  • Experience writing, coordinating, compiling, and submitting 510(k)s and other regulatory documents to the FDA is required.
  • Experience compiling Technical Files and Essential Requirements Checklists is required.
  • Global Regulatory Affairs experience, including interaction with regulatory bodies, is preferred.
  • Relevant experience in the medical device industry is required.
  • Knowledge of Quality System requirements (FDA 21 CFR 820 and ISO 13485) is required.
  • Experience working within the scope of the EU Medical Devices Directive/Medical Devices Regulation is required.
  • Prior participation in internal, FDA, and third party (Notified Body) audits is required.
  • Prior cross-functional team leadership is desired.
  • Ability to work independently, under minimal supervision.
  • SAP eligibility experience is preferred.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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