Senior Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistEmbark on an exciting journey that will revolutionize the way men suffering from BPH are treated. Join us as a Senior Regulatory Affairs Specialist and be at the forefront of regulatory science for medical robotics. Your mission? To support a deep culture of compliance while advocating for breakthrough medical innovations in the space of urological surgery. You'll be providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class II and III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies.What Your Day-To-Day Will InvolveAct as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirementsDevelop global regulatory strategies for new and modified productsSupport the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and Rest of World (RoW)Support regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)Independently identify and problem solve regulatory and compliance issues, and escalate to senior management as necessaryProvide effective communication, and quick responses to internal customersDrive continuous improvement in internal processes and customer satisfactionIdentify, develop, and mentor high performing regulatory talentAssure that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspectiveExecute US FDA 510(k) and Technical File creation and remediation, collaborating with cross-functional teams for required contentDraft and execute comprehensive regulatory impact assessments for design control changes to existing productsPerforms other duties and assignments as requiredThe Qualifications We Need You to PossessBachelor's Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)6 years' experience with a B.S. or 4 years' experience with a M.S. in regulatory submissions for medical devicesExperience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)Ability to work effectively on project teamsMust be able to manage multiple and competing priorities and manage programs with minimal oversightThe Qualifications We Would Like You to PossessM.S. or Ph.D. in a technical areaExperience working with both Class II and Class III medical devices.Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)Has a strong attention-to-detailStrong written, verbal, presentation, and organizational skillsStrong analytical and problem-solving skillsWorking knowledge of relevant ISO and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographiesAbility to identify risk areas and escalate issues as appropriatePay Range for this role:$148,550 to $174,770 PROCEPT BioRobotics