Company Overview
Our client is an innovative Medical Device organisation who focus is on the development and manufacture of radiotherapy systems that make cancer treatments shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives. Their radiation treatment delivery systems in combination with fully integrated software solutions set the industry standard for precision and cover the full range of radiation therapy and radiosurgery procedures.
They are looking for a Director/Senior Director Regulatory Affairs to join their leadership team at this critical time in their development to lead a dynamic/growing company’s Global Regulatory function the objective of ensuring the successful launch and continued marketing of the organisation’s life enhancing products.
Core Objectives
- Drive and lead the successful submission process for products worldwide, ensuring a transition from R&D to market.
- Build, develop, mentor a regulatory team with credibility with both internal and external stakeholders.
- Build and develop the regulatory culture
- Build and develop the company’s regulatory strategic program to meet and facilitate the company’s growth aspirations.
Candidate Requirements
- Bachelor of Science degree or equivalent in engineering/life sciences/suitable work experience in a technically related field in lieu of formal education.
- At least 10 years of experience in regulatory affairs, quality systems, process improvement/Lean, or product development/project management.
- At least 5 years of experience with medical device capital equipment or software products.
- Experience with managing complex regulatory or quality documentation for markets such as the: USA, China, Canada, EU, Japan, South Korea.
- Excellent knowledge of process development and continuous process improvement.
- Strong knowledge of worldwide regulatory and quality system requirements.
- Strong team leadership and people development skills.
- Excellent communication, organizational and customer relations skills.
- Ability to travel domestically and internationally up to 10%.
Our client is looking for an ideally be site located, however can offer a hybrid structure with a minimum of 2 days a week onsite.
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