On behalf of our client, an innovative global leader in advanced medical technology, we are looking for a Senior Director, Regulatory Affairs to join the organisation in a permanent capacity. This strategic role will drive global regulatory activities for a Class III medical device portfolio and support the development and approval of transformative therapies across international markets.
Key Responsibilities
* Develop and lead clinical regulatory strategies for Class III medical devices from early development through market approval.
* Interpret and apply complex regulatory requirements to clinical study planning and execution.
* Collaborate with cross‑functional teams including Clinical Affairs, Quality, R&D, and Regulatory Operations.
* Author, review, and submit high‑quality clinical regulatory documentation, including IDEs, PMAs.
* Lead EU CT Applications for medical devices and support the design of technical dossiers.
* Ensure submissions meet the latest regulatory requirements and are completed on schedule.
* Serve as primary regulatory contact for clinical matters with global health authorities (FDA, Notified Bodies, EMA, etc.).
* Engage and negotiate with regulatory authorities (i.e. FDA).
* Lead and prepare teams for pre‑submission meetings, advisory panels, and inspections.
* Provide regulatory guidance on clinical study protocols, informed consent forms, and investigator brochures.
* Ensure compliance with applicable clinical study regulations.
* Lead, mentor, and develop a high‑performing team.
* Actively participate in internal governance, risk assessments, and go/no‑go decisions related to clinical development.
Qualifications
* Minimum 10–12 years in regulatory affairs across biotechnology, pharma and medical devices, with significant time in medical devices. At least 5 years in a leadership role.
* Master’s degree in life sciences, biomedical engineering, or a related field required; advanced degree preferred.
* Deep knowledge and hands‑on experience with Class III medical devices, including IDEs, PMAs, and CE Mark submissions.
* Proven experience interacting with FDA and other global regulatory bodies on clinical issues.
* Strong understanding of clinical study design, statistical principles, and regulatory requirements for high‑risk medical devices.
* Familiarity with software as a medical device (SaMD) or combination products.
* Excellent leadership, communication, and cross‑functional collaboration skills.
Experience
* Experience with novel technologies or breakthrough device designation.
* Proven ability to develop regulatory strategies that balance compliance with business objectives.
* Deep understanding of global regulatory strategy, especially FDA, EU MDR and Asian markets.
* Advanced knowledge of US and global regulatory requirements for advertising, promotion, and labeling.
* Leadership, communication, and cross‑functional collaboration skills.
* Familiarity with digital and social media regulatory review.
* Prior participation in product launch preparation and execution.
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