Senior Regulatory Affairs Specialist

PROCEPT BioRobotics Corporation; San Jose (CA); On-site; USD 149,000 - 175,000; Full time

Job summary

PROCEPT BioRobotics Corporation is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for medical robotics devices. You will guide cross-functional teams on regulatory requirements, develop global strategies, and prepare submissions in the US, EU, and RoW to ensure compliance with FDA and international standards.

Ideal candidates will have 6+ years in regulatory submissions for medical devices, with a strong background in Class II/III devices, ISO 13485, EU MDR, and RAC

Qualifications

• Bachelor’s degree in a scientific discipline and relevant regulatory experience.
• Experience with 21 CFR 820, ISO 13485, EU MDR and related directives.

Responsibilities

• Lead regulatory representation on product development teams and communicate regulatory requirements.
• Develop global regulatory strategies for new and modified devices (Class II/III).
• Prepare and submit regulatory submissions in US, EU and RoW.
• Ensure compliance with FDA QMS and medical device regulations across programs.
• Mentor and develop regulatory talent within the team.

Skills

Regulatory submissions

FDA regulations

Cross-functional collaboration

Regulatory strategy

Documentation & writing

Leadership & mentoring

Education

Bachelor’s degree in science

MS or PhD (preferred)

Tools

QMS software

Job description

Company OverviewEmbark 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.Understanding PROCEPT's CultureAt PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!The Opportunity That Awaits YouAre 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.What Your Day-To-Day Will InvolveAct 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 requirementsDevelop global regulatory strategies for new and modified productsSupport 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 necessaryProvide effective communication, and quick responses to internal customersDrive continuous improvement in internal processes and customer satisfactionIdentify, develop, and mentor high performing regulatory talentAssure that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspectiveExecute US FDA 510(k) and Technical File creation and remediation, collaborating with cross-functional teams for required contentDraft and execute comprehensive regulatory impact assessments for design control changes to existing productsPerforms other duties and assignments as requiredThe Qualifications We Need You to PossessBachelor’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 devicesExperience 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 teamsMust be able to manage multiple and competing priorities and manage programs with minimal oversightThe Qualifications We Would Like You to PossessM.S. or Ph.D. in a technical areaExperience 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-detailStrong written, verbal, presentation, and organizational skillsStrong analytical and problem-solving skillsWorking knowledge of relevant ISO and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographiesAbility to identify risk areas and escalate issues as appropriatePay Range for this role:$148,550 to $174,770