Regulatory Affairs Specialist

Location : Newton MA 02466Shift : 8am-5pmResponsibilities :Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US market as well as markets outside of the US (e.g. Europe, Asia).In collaboration with subject matter experts, independently prepare and author regulatory documents such as Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions (IDE), and pre-market notifications, such as De Novo.Support and manage interactions with regulatory bodies (e.g., FDA, Notified Body)Support Clinical Affairs (Research) in Clinical Evaluation Reports, Post Market Surveillance Reports as needed. Lead the reporting of these technical documents to regulatory bodies as required by internal quality procedures.Participate and support new product development teams by defining regulatory requirements for product development along with ensuring adherence to internal Design Control SOPs;Support clinical affairs and clinical operations as needed (i.e., periodic reporting of safety to regulatory agencies)Support document change control activities that require regulatory approval.Review validation protocols and reports to support regulatory submissions. Required skills to have for the success of this role:Bachelor’s degree in a scientific discipline required, Master’s degree or higher preferred.Minimum of 15 years’ experience in strategic Clinical and Regulatory Affairs tactical executions (including authoring regulatory submissions and demonstrating favorable outcomes such as regulatory approvals) a must;Proficiency in ISO 13485, 21CFR820 (including Design Controls and Risk Analysis), EU MDR Regulation (EU) 2017/745 is a must.Experience in medium to high-risk devices with, along with De Novo or PMA applications, and demonstrated approvals are a must.Experience in generating, updating and managing Clinical Evaluation Plans/Reports and Post Market Surveillance Plans/Reports is a must.Experience with authoring and managing Technical Files and Design Dossiers conforming with Europe’s Medical Device Regulation is a must.Proficiency and experience in rest of world regulatory submissions requirements for premarket approvals or clinical trial authorizations (e.g., Asia, South America) are ideal.Experience in project management and associated project management tools (e.g., Microsoft Project) is a must.Knowledge and experience in clinical affairs including IDE submissions are ideal.Experience with complex electromechanical, software controlled robotic systems, AI, SaMD, neuro devices is idealExperience with FDA inspection (QSIT) and Notified Body audits is required.Experience with FDA BIMO inspection is ideal.RAC-devices certificate preferred.Ability and willingness to work in a lean, fast-paced environment.Willing to travel up to 5%.

Salary : $60 - $68