:
1. Market Access and Licensing: Acquire pre-market licenses, handle renewals, and manage license changes globally.
2. Market Analysis: Conduct market analysis and develop strategies to improve market access.
3. Partner Engagement: Engage with healthcare providers and regulatory authorities.
4. Economic Evaluation: Perform economic evaluations and health technology assessments.
5. Develop and report important metrics regarding licensing activities.
6. Acquire and communicate actionable regulatory intelligence globally.
7. Cross-Functional Coordination: Collaborate with Product RA on QMS updates and market access strategies.
Minimum Qualifications:
8. Bachelor’s/Master’s Degree, diploma, or equivalent combination of qualifications in life science, engineering, legal, or related fields.
9. Validated experience with international regulatory affairs within the medical device or IVD industry.
Skills:
10. Excellent communication and presentation skills at all organizational levels.
11. Expertise in multinational regulatory strategy, risk-benefit analysis, and collaboration with internal and external stakeholders.
12. Strong project management skills.
13. Ability to develop and engage in a high-performance team dedicated to accountability.
14. Capability to lead, influence, and innovate within a cross-functional environment.
Preferred Qualifications:
15. Previous Thermo Fisher experience in Regulatory function
16. RAC accreditation
At Thermo Fisher Scientific Inc., we are committed to fostering an inclusive and diverse workplace. We are an equal opportunity employer and value the strengths and perspectives that each individual brings to our team. We strive to provide reasonable accommodations and adjustments to applicants and employees with disabilities to ensure equal access to employment opportunities. If you require any accommodations or adjustments during the application process or throughout your employment, please let us know.
Join our exceptional team and take the next step in your career as an executive assistant at Thermo Fisher Scientific Inc.