Principal Regulatory Affairs Specialist

Gulf Coast Automation Group•San Jose, CA

7d•Hybrid

About The Position

Embark on an enriching journey with PROCEPT BioRobotics, 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.

Requirements

Bachelor'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 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

Nice To Haves

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

Responsibilities

Act 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 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 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