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Our science-driven medical device client is redefining expectations and advancing the field through cutting-edge solutions and therefore hiring a Sr. Director of Regulatory Affairs. The Sr. RA Director reports to the SVP of Clinical and Regulatory Affairs and will support the strategic direction, as well as lead the day-to-day execution of global regulatory activities. This role will be responsible for preparing high-quality regulatory submissions, supporting interactions with the FDA and other international regulatory bodies, and ensuring compliance with global requirements related to market authorizations, post-market surveillance, and regulatory reporting. Are you a Regulatory Director looking to fast-track to VP, then this role is for you!

Your role with the company:

  • Create and execute global regulatory strategy for all products in alignment with business goals.
  • Serve as a strategic advisor to the executive team on the regulatory implications of product and process changes.
  • Develop and lead a high-performing global Regulatory Affairs team that supports company objectives across product lifecycles.
  • Oversee department budget planning and resource allocation to ensure alignment with regulatory and business priorities.
  • Ensure Regulatory Affairs participation on cross-functional project teams supporting new product development and product modifications.
  • Lead timely renewals of global licenses, certificates, and product registrations.
  • Provide guidance on the application of external standards across all projects.
  • Maintain complete, audit-ready regulatory documentation and manage global submission packages.
  • Direct regulatory activities related to field corrective actions and ensure appropriate product re-submissions and ongoing approvals.
  • Support Quality Assurance in maintaining ISO/CE Mark certifications and related regulatory audits.
  • Monitor evolving global regulatory requirements and assess their impact on Anteris products and systems.
  • Conduct regulatory assessments for reportability and submit FDA MDRs and international vigilance reports as needed for tissue-based products.
  • Review Engineering Change Requests (ECRs) for global regulatory impact.
  • Lead or participate in regulatory review of promotional materials.
  • Author, review, and approve internal procedures related to regulatory affairs operations and compliance.

Desired Profile:

  • Bachelor’s degree in a technical field required; advanced degree preferred.
  • 10–12 years of experience in the medical device industry, ideally with exposure to structural heart technologies.
  • At least 5 years of experience leading a Regulatory Affairs team.
  • Hands-on leadership of regulatory submissions for Class III/PMA devices, including FDA (IDE, PMA) and EU (MDR, CA, CE Mark) pathways.
  • Experience working with Notified Bodies through CE submissions and post-market requirements.
  • Strong knowledge of global regulatory standards and quality systems, including ISO 13485, GMP, GCP, GLP, QSR, and MDR.
  • Exceptional communication skills with the ability to craft clear, concise regulatory documents and collaborate across functions and levels.
  • Proven project management skills, with a track record of driving robust submissions and compliance initiatives.
  • Innovative, solution-oriented mindset with a strong focus on regulatory rigor and business alignment.
  • Demonstrated leadership that fosters cross-functional collaboration, champions innovation, and drives accountability.
  • A disciplined, strategic approach to risk management and regulatory compliance.
  • RAC certification preferred.
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