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Director of Regulatory Affairs

2 months ago

Aliso Viejo, United States Meet Full time

Overview

Reporting to the Senior Vice President of Clinical and Regulatory Affairs, the Director of Regulatory Affairs will play a crucial role in shaping and executing a top-tier regulatory strategy for companies technology and products. This role involves preparing, analyzing, and submitting dossiers to various regulatory bodies to support the company's business growth.

Essential Duties and Responsibilities

The Director of Regulatory Affairs will work closely with various functional areas, including R&D, Manufacturing, Quality Assurance, and Commercial. Key responsibilities include:

  • Preparing international regulatory submissions and FDA submissions, including Technical Documents, Technical Files, Device License Applications and Amendments, and PMAs.
  • Identifying and collecting data necessary for filings, responses to inquiries, and registration maintenance to support product commercialization globally.
  • Creating and annually updating the Clinical Evaluation Report, including State of the Art and Subject Literature Review.
  • Leading the preparation and review of regulatory submissions in line with US and international requirements, ensuring timely responses to Health Authorities during application reviews.
  • Acting as a regulatory affairs subject matter expert, providing training and guidance to team members as needed.
  • Authoring and reviewing regulatory procedures and updating them as necessary.
  • Demonstrating a strong understanding of regulatory requirements for medical devices, including FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), ISO standards (e.g., ISO 13485, ISO 14971), and international regulatory frameworks.
  • Exhibiting excellent communication skills and the ability to collaborate effectively with cross-functional teams.
  • Participating in cross-functional project teams and serving as a global regulatory advisor.
  • Reviewing technical documentation to ensure it supports regulatory applications.
  • Maintaining comprehensive knowledge of competitive technologies, as well as medical and technical developments related to the company's products.

Required Knowledge, Skills, and Abilities

  • Extensive experience with premarket regulatory activities in the US, EU, and other global markets.
  • Proven success in regulatory submissions and interactions with regulatory agencies (FDA, Notified Bodies, etc.).
  • Ability to thrive in a fast-paced environment.
  • High integrity and character, with a fair and principled approach.
  • Creative technical skills leading to innovative development processes.
  • Strong analytical and problem-solving skills with a knack for creative solutions.
  • Ability to prioritize projects, foster enthusiasm, and encourage innovation and creativity.
  • Solid project management skills to handle multiple projects and manage timelines with urgency.
  • Confident, decisive, and excellent communication skills in both oral and written formats, along with strong listening, presentation, and problem-solving abilities.
  • Effective interfacing with all organizational levels and functions.

Supervisory Responsibilities

  • Managing internal and external resources.

Education, Experience, and Training

  • 7-10 years of experience in regulatory affairs within the medical device industry, preferably with experience in ophthalmic and implantable devices.
  • Bachelor's or Master's degree.
  • A hands-on approach that fosters a strong, cohesive, team-focused environment.
  • Technical and continuous improvement experience, emphasizing the management and deployment of continuous product development for medical devices.
  • Proven success in therapy innovation, technology implementation, and commercialization.
  • Track record of achieving and maintaining high-quality standards.
  • Completion of training requirements as per the position's training plan maintained in the document control system.
  • Completion of training on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy, and TRN-10009 Code of Business Conducts and Ethics within 30 days of hire and annually.

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