As a Principal Consultant US Market Expert, you will shape regulatory and commercial strategies for medical device innovators targeting the U.S. healthcare market. Your role centers on guiding clients through FDA pathways—including 510(k), De Novo, PMA, and IDE—by designing clear, compliant strategies that align with business objectives.
Key Responsibilities
- Lead end-to-end regulatory planning for U.S. market entry, from initial pathway analysis to submission preparation and FDA engagement.
- Manage high-level interactions with the FDA, including Pre-Submission meetings, IDE discussions, and responses to regulatory feedback.
- Develop and expand a portfolio of client relationships, identifying new opportunities and supporting revenue growth through strategic advisory services.
- Translate complex regulatory expectations into practical, business-focused guidance for executive and technical teams.
- Represent the firm at industry events, conferences, and client meetings, reinforcing thought leadership in the U.S. MedTech space.
- Collaborate with global consultants while operating independently in a client-driven consulting environment.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related discipline.
- Minimum of 10 years in medical device regulatory affairs, with hands-on experience in FDA submissions and client-facing roles.
- Proven track record in managing 510(k), PMA, De Novo, and IDE processes, including preparation of briefing documents and leading agency discussions.
- Strong professional network within the U.S. medical device industry and demonstrated ability to grow client engagements.
- Excellent communication and consulting skills, with the ability to advise senior stakeholders and influence decision-making.
- Experience balancing autonomous work with cross-border team collaboration.
- Familiarity with international regulatory frameworks is an advantage.
- Willingness to travel domestically and internationally as needed for client support and business development.
