Senior Regulatory Affairs Specialist

Company Overview

Embark on an enriching journey with PROCEPT Bio Robotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders.

That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

Are you ready to embark 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.

• Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and 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 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 elevate 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 U.S. FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspective.
• Execute U.S. 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.
• Perform other duties and assignments as required.

• Bachelor’s Degree in a scientific discipline (e.g., Chemistry, Life Sciences, Biology or equivalent vocational qualifications).
• 6 years’ experience with a B.S. or 4 years’ experience with an 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.
• Must be able to manage multiple and competing priorities and manage programs with minimal oversight.

• M.S. or Ph.D. in a technical area.
• Experience working with both Class
  
  II and Class
  
  III medical devices.
• Certification is a plus (e.g., 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 the U.S., EU (EUMDR), and other international geographies.
• Ability to identify risk areas and elevate issues as appropriate.

$148,550 to $174,770