Principal Regulatory Affairs Specialist

About the job Principal Regulatory Affairs Specialist


Principal Regulatory Affairs Specialist

San Jose, CA

RAQA /Full-Time /Hybrid

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 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.

The Opportunity That Awaits You:

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.

What Your Day-To-Day Will Involve:

• 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

The Qualifications We Need You to Possess

• 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

The Qualifications We Would Like You to Possess

• 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

For US-Based Candidates Only

Work Authorization Status: Citizen / Permanent Resident

For this role, the anticipated base pay range is $190,000-210,000 per year.

Plus, eligibility for an annual bonus and equity/RSUs

Understanding PROCEPT's Culture

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!

BENEFITS OF WORKING AT PROCEPT!


PROCEPT's health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.

PAY RANGE TRANSPARENCY

Procept is committed to fair and equitable compensation practices. The pay range(s) for this role represents a base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.

WORK ENVIRONMENT

We'll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.

PROCEPT BioRobotics - Applicant Privacy Notice

When you submit an application on this site, PROCEPT BioRobotics collects the personal information you provide. This may include your name, email address, phone number, résumé or CV, LinkedIn profile, and any optional demographic information you choose to share, such as gender or ethnicity. We use this information to review your application and assess your suitability for the role.

To learn more about how we handle personal information, including your rights under applicable privacy regulations, please read our full Privacy Notice at: [Privacy Policy].

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.