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Director, Regulatory Affairs

Chicago, IL

Posted: 09/11/2020 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2637

Job Description

The Director, Regulatory Affairs with a focus on combination products will define, develop and lead combination product strategies to maximize regulatory success, strengthen the product development plan, and enable patient access in alignment with program objectives.

Essential Job Functions:
  • Defines, develops and leads combination product regulatory strategies to maximize regulatory success towards achievement of program objectives.
  • Manages, plans and directs all aspects for the successful preparation, submission and timely. approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned programs.
  • Stays current with combination product regulations for impact on drug development plans, registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance.
  • Manage all Regulatory responsibilities for assigned manufacturing changes and new product launches, including but not limited to: developing and executing process validation protocols and publishing reports; develop area, process, and supplier quality plans and out of control action plans; implement Statistical Process Control (SPC) in manufacturing processes where applicable.
  • Provides strategic guidance / advice on emerging trends with respect to combination product regulations and changes.
  • Provide regulatory support and leadership for Design Control activities.
  • Participates in interactions with FDA and other Health Authorities  for all programs in scope.

Skills and Qualifications:
  • Bachelor’ s Degree in a scientific, engineering, industrial design, or similar discipline is required, advanced degree preferred.
  • 10+ years of experience with increasing responsibility years working with medical, commercial or industrial products from pharmaceutical, regulatory, design, testing, validation, ergonomics and human factor perspective.
  • The ideal candidate will have a combination of regulatory, pharmaceutical, device design, testing, human factors and usability expertise in regulated environment.
  • Experience with Health Authorities, Verification & Validation protocols and test reports.
  • Experience with device regulatory requirements and development processes for combination products.
  • Experience writing technical documents like test reports, technical memos, input requirements documents, human factors protocols, etc.
  • Experience preparing information for  NDA, BLA, 510k, IDE, and PMA submissions is a plus.
  • Strong knowledge of regulations, current industry practices, and interpretation and application practices.
  • Competencies:  Analytical skills, Risk Management, Attention to Detail, Strategic Leadership, Presentation skills, Facilitation skills, Written and Verbal Communication skills, Teamwork & Collaboration skills, Organizational skills.
  • US and International travel approximately 20%
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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