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Company Overview 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 commit…
Skills: Regulatory Strategy, FDA Submissions, EU MDR, Class II and III Devices, Quality Management Systems
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Company Overview 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 commit…
Skills: Regulatory Strategy, FDA Submissions, 510(k), IDE, EU MDR
San Jose, California, United States · On-site
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Position Rank and Title: Assistant Professor School/Department Name: College of Social Sciences, Department of Chicana and Chicano Studies Compensation: Commensurate with qualifications, experience, and rank as establishe…
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Trial Attorney – Criminal Defense | Michael & Associates, San Jose, CA Michael & Associates is setting a new standard for criminal defense in California. Building on our exceptional success in Texas, we are expanding to …
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San Jose, California, United States · On-site
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Astera Labs (NASDAQ: ALAB) provides rack-scale AI infrastructure through purpose-built connectivity solutions. By collaborating with hyperscalers and ecosystem partners, Astera Labs enables organizations to unlock the fu…
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San Jose, California, United States · On-site
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San Jose, California, United States · On-site
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San Jose, California, United States · On-site
$32/hr–$43/hr
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Skills: Employee Relations, Conflict Resolution, Workplace Investigations, Labor Law Compliance, Performance Management
San Jose, California, United States · Hybrid
$58/hr–$64/hr
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San Jose, California, United States · Remote OK
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San Jose, California, United States • On-site
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Lead regulatory representative for product development teams, focusing on global regulatory strategies for Class II and III medical devices. Responsible for preparing submissions for the US, EU, and other international geographies while ensuring compliance with FDA and EU-MDR regulations.
Requires a Bachelor's degree in a scientific discipline with 4-6 years of experience in medical device regulatory submissions. Proficiency in 21 CFR 820, ISO 13485, and international regulatory standards is essential.
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.
At 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!
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 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
Draft and execute comprehensive regulatory impact assessments for design control changes to existing products
Performs other duties and assignments as required
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
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:
Aquablation therapy - the BPH treatment of choice for all prostates.
PROCEPT BioRobotics is a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. PROCEPT BioRobotics manufactures the AQUABEAM® and HYDROS™ Robotic Systems. The HYDROS Robotic System is the only AI-Powered, robotic technology that delivers Aquablation therapy. PROCEPT BioRobotics designed Aquablation therapy to deliver effective, safe, and durable outcomes for males suffering from lower urinary tract symptoms or LUTS, due to BPH that are independent of prostate size and shape or surgeon experience. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. The Company has developed a significant and growing body of clinical evidence with over 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy. The HYDROS Robotic System is currently cleared for use in the United States, EU and UK only.
Offices: 150 Baytech Dr, San Jose, California 95134, US
Based on 125 listings with disclosed salaries, most legal jobs in San Jose, CA pay between $71k–$247k per year. Individual offers vary with seniority, company size, and specialization.
There are currently 137 open legal positions in San Jose, CA listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Adobe, Axiado Corporation, Lyten, Vialto, Modern Family Law, among others. Browse the listings above to see every active employer.
Yes — 53 of the 137 open legal positions offer remote or hybrid work (18 remote, 35 hybrid).
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