Regulatory Affairs Specialist II

The Regulatory Specialist works in the Global RA team and is responsible for the registration of PDx products in global markets including EMEA, USA, LATAM and AsiaPac. This includes interpreting local regulatory requirements, preparing submission documentation and tracking registrations to completion.
A Day in the Life:
Author, compile and submit registration documentation to ensure it aligns with regional regulations.Track and maintain files for annual licences, registrations and listings with Regulatory AuthoritiesIdentify, collect, and apply information on local regional regulatory intelligence and other related information. E.g. through involvement in Industry associationsApproval of change requests to ensure compliance and the requirement for regulatory submissionsAct as Regulatory representative on project teams, providing regulatory expertise. and mentorship.Support external and internal site audits, perform RA reviews, and ensure compliance with company policies and regulations (including MDSAP and ISO13485)Promote a process improvement culture through PPI activities, to improve quality and efficiency of the RA processes..
Keys to Success:
EducationB.S. in Chemistry, Biology, Biochemistry, or a related science required.Regulatory Qualification is an advantage.
ExperienceProven experience in a regulatory or quality environment.

Knowledge, Skills, AbilitiesKnowledge of ISO13485, MDSAP and ISO9001Experience of preparing regulatory submission documentationStrong interpersonal, verbal and written communication skills

At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering innovative solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting and fulfilling career with us.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!