Senior Regulatory Affairs Specialist

About the role

Join us as a Senior Regulatory Affairs Specialist and be at the forefront of regulatory science for medical robotics. Your mission is to support a deep culture of compliance while advocating for breakthrough medical innovations in the space of urological surgery.

Responsibilities

• Act as a lead regulatory representative on product development teams, communicating regulatory requirements and the impact of regulations to project teams.
• Provide input related to FDA and international product registrations and licensing requirements.
• Develop global regulatory strategies for new and modified products.
• Support the monitoring and interpretation of current and new regulatory requirements and international standards for U.S. and Rest of World (RoW).
• Comply with new and existing regulations such as FDA Medical Device Regulations, EU-MDR, and other international standards.
• Identify and problem-solve regulatory and compliance issues, escalating as necessary to senior management.
• Communicate effectively with internal customers and drive continuous improvement in internal processes and customer satisfaction.
• Identify, develop, and mentor high-performing regulatory talent.
• Assure adherence to US FDA Quality Management System (QMSR) requirements from the 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.

Requirements

• Bachelor’s Degree in a scientific discipline (Chemistry, life sciences, Biology) or equivalent vocational qualifications, with 6 years of experience with a B.S. or 4 years with a M.S. in regulatory submissions for medical devices.
• Experience 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 and manage multiple and competing priorities.

Qualifications

• M.S. or Ph.D. in a technical area, with 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, and strong analytical and problem-solving skills.
• Working knowledge of relevant ISO and EN standards, and 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

The pay range for this role is $148,550 to $174,770, with a 15% bonus and RSUs.