Staff Regulatory Affairs Specialist

The Opportunity

Are you ready to embark on an exciting journey that will revolutionize the way men suffering from BPH are treated? Join us as a Staff 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.

• Act as a lead regulatory representative on core product development teams
• Communicates regulatory requirements and impact of regulations to project teams
• Provides input related to FDA and international product registrations and licensing requirements
• Develops global regulatory strategies for new and modified products
• Supports the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and Rest of World (RoW)
• Leads regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
• Independently identifies and problem solves regulatory and compliance issues, and escalates to senior management as necessary
• Provides effective communication, and quick responses to internal customers
• Drives continuous improvement in internal processes and customer satisfaction
• Identifies, develops, and mentors high performing regulatory talent
• Assures that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspective
• Executes US FDA 510(k) and Technical File creation and remediation, collaborating with cross-functional teams for required content
• Drafts and executes comprehensive regulatory impact assessments for design control changes to existing products

Qualifications

• Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
• 8 years experience with a B.S. or 6 years experience with a M.S. in regulatory submissions for medical devices
• Experience 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)
• M.S. or Ph.D. in a technical area
• Experience working with both Class II and Class III medical devices
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
• Strong attention-to-detail
• Strong written, verbal, presentation, and organizational skills
• Strong analytical and problem-solving skills
• Working knowledge of relevant ISO and EN standards
• Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies
• Ability to identify risk areas and escalate issues as appropriate