Global Regulatory Head

ClinicalPro is seeking a Global Regulatory Head for a leading Medical Devices organisation located in the USA.

This individual will be responsible for developing and implementing regulatory policies, procedures, and programmes.

Must be eligible to work in the USA.

Responsibilities

• Develops strategy, provides people with technical direction, and makes sure that implementation achieves the intended aims.
• Keeps correct records and sends thorough reports to the proper executives.
• Exemplary organisation, punctuality, and attention to detail.
• Ability to creatively put plans into action and think strategically.
• Contributes to the implementation of strategy, policy, and pertinent policies and procedures.
• Creates company strategies.
• Shape evolving market demands and regulatory constraints.
• Monitors project progress and establishes budgets and timelines.
• Solves problems effectively and swiftly.
• Ensures satisfaction with stakeholders.
• On-time project delivery; cross-functional collaboration to identify and explain regulatory needs.
• Oversees the application of new regulations to guarantee compliance.
• Recognises extra project needs and keeps track of spending.
• Evaluates project performance using the R&D Centre of Excellence.
• Builds and manages teams.
• Can manage several tasks.
• Engages in proper communication.
• Engagement with regulators, notified bodies, and trade associations.
• Takes part in the integration of new acquisitions and due diligence analysis.
•  Actively engages in business forums and outside scientific and technological conferences as required to keep up regulatory knowledge and competence.

Skills and Requirements

• A degree in life science is necessary.
• A higher degree is preferred.
• Device and product development.
• 9–10 years of experience.
• An extensive understanding of combination product development and registration processes worldwide, including EU MDR standards and expectations.
• Knowledgeable about communicating with Notified Bodies and other regulatory organisations.
• Understanding of important regulatory processes for pharmaceuticals, medical devices, and drug-device combinations.

Apply

If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.

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