Regulatory Affairs Specialist
The Global Regulatory Affairs (RA) department coordinates the activities of all Topcon regulatory affairs team business.
This global function sets the RA strategy for the corporation, collecting changes in the RA landscape, evaluating the impact on the corporate business, and developing strategies to implement these changes.
Besides giving guidance on RA matters to all other functions within Topcon.
The candidate will be mainly in charge for coordinating marketing authorizations to US FDA and serving as the main contact point for the corporation for all issues related to US FDA regulations and policies.
- Main tasks
- Develop approval strategy for product marketing in the USA (Class I, Class II, and De Novo)
- Focus on active medical devices and Software (SiMD, SaMD)
- Support of Clinical Trials team in the US (Protocol development, CSR, statistics, etc.)
- Prepare 510(k) dossiers for FDA approval
- Review 510(k) dossiers
- Train colleagues on FDA regulations, policies, and FDA submission documentation requirements (worldwide)
- Coordinate all activities with the US team to incorporate up-to-date information and requirements from FDA
- Conduct internal trainings on RA requirements
- MSC in Engineering, Science or related discipline required
- Experience in the US approval process (3-5 years)
- Minimum 10 successful submissions (510(k))
- Experience with the approval of software with a focus on cybersecurity desired
- Experience in ophthalmology / optics preferred
- Deep knowledge of the common regulations and standards
- FDA 21 CFR 800, Regulation 2017/745 (MDR), IEC 62304, IEC 60601-1 Clause 14
- Knowledge of ISO 13485 and MDSAP are preferred
- Very good communication skills in an intercultural environment
- Good English skills
- Willing to travel internationally (20%)