The Opportunity That Awaits You: 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.
What Your Day-To-Day Will Involve:- Act as a lead regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements
- Develop global regulatory strategies for new and modified products
- Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and Rest of World (RoW)
- Lead 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 necessary
- Provide effective communication, and quick responses to internal customers
- Drive continuous improvement in internal processes and customer satisfaction
- Identify, develop, and mentor high performing regulatory talent
- Assure that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspective
- Execute US FDA 510(k) and Technical File creation and remediation, collaborating with cross-functional teams for required content
- Draft and execute comprehensive regulatory impact assessments for design control changes to existing products
- Performs other duties and assignments as required.
The Qualifications We Need You to Possess- 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)
- Ability to work effectively on project teams
- Must be able to manage multiple and competing priorities and manage programs with minimal oversight
The Qualifications We Would Like You to Possess - 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)
- Has a 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
Pay Range for this role:
