Director Regulatory Affairs

Posted 14 June 2024
LocationLaguna Hills
Contact NameJeremy Burling

Job description

About the job

This individual will join our client's regulatory team and collaborate with other departments like R&D, Manufacturing, Quality Assurance, and Commercial. Here's what you'll be responsible for:


  • Preparing Regulatory Submissions: You'll draft submissions for international markets and the FDA, including Technical Documents, Files, Device Applications/Amendments, and PMAs.
  • Data Gathering and Support: Identify and collect data needed for filings, responses to inquiries, and registration maintenance. This ensures products meet global regulatory requirements for commercialization.
  • Clinical Evaluation Reports: You'll be responsible for creating and updating annual Clinical Evaluation Reports, including State of the Art and Subject Literature Reviews.
  • Regulatory Submissions Expertise: As a key contributor, you'll prepare and review submissions following US and international regulatory requirements. You'll also ensure complete and timely responses to Health Authorities during application review.
  • Subject Matter Expert: Serve as a resource on regulatory affairs, providing training and guidance to team members as needed.
  • Regulatory Procedures: Author and/or review regulatory procedures and update them when necessary.
  • Regulatory Knowledge: Possess a strong understanding of medical device regulations, 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.
  • Communication and Collaboration: Demonstrate excellent communication skills and collaborate effectively with cross-functional teams.
  • Project Team Participation: Actively participate in cross-functional project teams as a global regulatory advisor.
  • Technical Documentation Review: Review technical documentation to ensure it supports regulatory applications.
  • Competitive and Technical Awareness: Maintain a strong understanding of competitive technologies and medical/technical developments relevant to our client's products.


What You Bring to the Table:

  • Proven Regulatory Experience: This role requires strong experience with pre-market regulatory activities in the US, EU, and other global markets.
  • Success with Regulatory Agencies: You have a proven track record of successful regulatory submissions and interactions with regulatory agencies (FDA, Notified Bodies, etc.).
  • Fast-Paced Environment: You thrive in a dynamic and fast-paced work environment.
  • Integrity and Character: You possess high integrity, character, and are a person who is tough-minded, fair, and principled.
  • Creative Problem-Solving: You have strong analytical and problem-solving skills with the ability to develop innovative solutions.
  • Project Management Skills: You can prioritize tasks, manage multiple projects, and set/manage timelines with urgency.
  • Communication and Interpersonal Skills: You are self-confident, decisive, and possess excellent communication skills in both written and oral formats. Additionally, you are a great listener, presenter, and problem solver.
  • Teamwork and Collaboration: You can interface effectively at all levels and functions within the organization.


Supervisory Responsibilities:

  • Manage internal and external resources.


Education and Experience:

  • 7-10 years of experience in regulatory affairs within the medical device industry, with a preference for implantable devices.
  • Bachelor's or master's degree.
  • A "hands-on" style that fosters a strong, cohesive, team-focused work environment.
  • Technical and continuous improvement experience with emphasis on managing and deploying continuous product development for medical devices.
  • A proven track record in therapy innovation, technology implementation, and commercialization.
  • A demonstrable track record of achieving and maintaining high-quality standards.
  • Complete training as outlined in the company's training plan, including mandatory training on Insider Trading, Anti-Bribery/Corruption Policies, and Code of Business Conduct and Ethics.