Director, Regulatory Affairs

Glen Burnie, Maryland
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Type: Contract

Category: Scientific & Clinical

Job ID: 155557

Date Posted: 09/16/2020


Job Title: Director of Regulatory Affairs-Medical Device
Location: Remote
Start Date: Immediate

 

Responsibilities:

  • Develops technical content, format and accountability for regulatory submissions and related supplements and amendments.
  • Advises project teams regarding the development and implementation of regulatory strategy through the analytic, GMP and clinical development processes.
  • Establishes and maintains excellent relationships with regulatory agency personnel.
  • Responds to requests for additional data, organizes and manages participation in meetings.
  • Negotiates directly with regulatory authorities regarding company's filings.
  • Reviews and approves technical data and verifies accuracy of clinical data and execution of preclinical and clinical projects to regulatory authorities.
  • Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.
  • Serves as regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
  • Coordinates with other departments, corporate or marketing partners, and outsourcing partners to achieve project goals.
  • Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
  • Reviews all external materials for regulatory compliance.
  • Serve as overall global regulatory lead accountable for all regulatory aspects of assigned projects, including development and implementation of the global regulatory development plan for the project.
  • Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables.

Requirements:

  • Advanced education (e.g., MS, PhD, MD,) highly preferred.
  • Valid passport and able to travel.
  • Typically 15 years experience in the medical device industry.
  • Management and leadership experience at project level, experience with strategic initiatives/issues.
  • 12 years medical device regulatory affairs experience with regulatory processes including direct contact with regulatory agencies; full knowledge of FDA 510(k), EU CE Clearance & notified body regulations and guidelines, and the ability to provide interpretations of the information to others.
  • Prior medical device regulatory affairs managerial experience, with direct supervision of senior level regulatory professionals or equivalent leadership role required.
  • Strong knowledge of current US and EU regulations.
  • Experience with developing and implementing competitive regulatory strategies.
  • Solid understanding of dossier requirements for 510 (k), PMA, CTA, Design Master File, ISO 13485 and 21 CFR 820.
  • Ability to strategically interpret and respond to requests from regulatory agencies.
  • Demonstrated track record in securing product approvals and maintaining a complex portfolio.
  • Direct experience of leading regulatory authority meetings in different phases of drug development.
  • Proven leadership skills in a cross-functional team environment. International experiences a plus.
  • Ability to interact externally and internally to support global business strategy.
  • Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
  • Must possess knowledge and experience with FDA and EMA electronic authoring, global standards from ICH, GHTF (through IMDRF), WHO and ISO

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