Head of Regulatory Affairs

Our client, a leading organization in the medical device industry, is seeking an experienced Head of Regulatory Affairs to lead and oversee regulatory strategy for their portfolio of high-risk medical devices. This key leadership position will drive regulatory activities across global markets, ensuring compliance with applicable regulatory requirements and standards, including but not limited to EU MDR, FDA regulations, and ISO standards.

The ideal candidate will have substantial experience with regulatory frameworks for high-risk devices, including Class II/III devices. This role involves collaboration across multiple teams, including R&D, Quality Assurance, and Clinical Affairs, and provides the opportunity to influence strategic decisions at a senior level.

Key Responsibilities:

• Develop and Lead Regulatory Strategy:
  Shape and implement global regulatory strategies to ensure compliance for high-risk medical devices in key markets such as the EU, US, and other international regions.

• Team Leadership:
  Lead and manage the Regulatory Affairs team, fostering a high-performance culture and ensuring the professional development of team members.

• Regulatory Filings & Submissions:
  Oversee the preparation, submission, and management of all regulatory submissions, including CE Mark applications, 510(k)s, and Pre-Market Approval (PMA) filings.

• Collaboration & Cross-Functional Support:
  Collaborate with internal teams (R&D, Quality, Clinical Affairs) to ensure products meet regulatory requirements from development through post-market stages. Provide regulatory guidance on clinical trials, labeling, and marketing materials.

• Maintain Regulatory Compliance:
  Ensure the company’s products comply with all applicable regulatory requirements and guidelines. Lead post-market surveillance activities, including vigilance reporting and adverse event management.

• Monitor Regulatory Changes:
  Stay updated on evolving global regulatory landscapes, identify impacts to the company’s product portfolio, and proactively adapt strategies to remain compliant.

• Stakeholder Management:
  Act as the primary contact for regulatory bodies and authorities, managing communications, audits, and inspections as needed.

• Risk Management & Inspection Readiness:
  Ensure the company is inspection-ready at all times by maintaining complete and accurate regulatory documentation. Manage risk assessments and corrective actions related to regulatory non-compliance.

Required Qualifications:

• Educational Background:
  Bachelor’s degree in life sciences, engineering, or a related field (advanced degree preferred).

• Experience:

  • Minimum of 8-10 years in Regulatory Affairs within the medical device industry, with a specific focus on high-risk devices.
  • Strong track record in leading regulatory submissions and gaining approvals for high-risk devices across global markets (e.g., CE Mark, FDA 510(k), PMA).
  • Demonstrated experience managing and developing regulatory teams.

• Technical Expertise:

  • In-depth knowledge of major regulatory frameworks, including EU MDR, FDA regulations, ISO 13485, and ISO 14971.
  • Familiarity with global standards and best practices for high-risk medical devices (e.g., IVD, SaMD).

• Skills:

  • Excellent leadership, communication, and stakeholder management skills.
  • Strong analytical and problem-solving abilities, with a proactive approach to regulatory challenges.
  • Ability to manage multiple projects and deadlines in a fast-paced, highly regulated environment.

How to Apply:
Interested candidates should submit their CV to a.brenner@panda-int.com or reach out for more information.