Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist San Jose CARAQA Full-Time Hybrid apply for this job

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, and 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. Youll 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

• Lead regulatory labeling activities in support of global regulatory submissions for product registrations and variations.
• Lead authorship responsibilities for content within User Manuals, product inserts, and on-product labeling.
• Provide SME input on global regulatory labeling requirements and standards.
• Apply style guidelines and branding standards to new and modified product labeling.
• Verify that labeling complies with all applicable requirements.
• Manage external service providers in designing graphic content for label artwork using design software such as Adobe Illustrator, as well as dedicated labeling software such as Bartender.
• Create and revise label items within the companys document control system by drafting and releasing engineering change orders.
• Contribute to Labeling department process improvement initiatives.
• Represent the Regulatory Affairs labeling function on project teams by collecting potential labeling inputs from other departments, interpreting the impact that projects such as design changes will have on labeling content, and implementing necessary modifications to the product labeling.

The Qualifications We Need You to Possess

• Bachelors degree in a scientific or engineering field (preferred).
• Five (5-plus) years work experience in the medical device field.
• Minimum of 5 years experience working in regulatory affairs in a medical device company.
• Knowledge of Title 21 of the US Code of Federal Regulations (21 CFR 800-1299).
• Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k).
• Experience with European Medical Device Directive 93/42/EEC with 2007/47/EC and EU Medical Device Regulation 2017/745.
• Experience with Quality Management System Standard ISO 13485 is required.
• Experience working cross-functionally with engineering, marketing, manufacturing, and legal teams to facilitate completion of labeling and artwork assignments.
• Excellent written communication skills, especially with technical information.
• Proficiency in Microsoft Office Suite (preferred).
• Precise, thorough, and analytical.
• Proactive and adaptable to a fast-paced work environment, including managing multiple projects simultaneously.

The Qualifications We Would Like You to Possess

• Advanced degree or credential in regulatory affairs (preferred).
• Hands-on experience maintaining Instructions for Use (IFUs), product labels, capital equipment documentation, and packaging labels in compliance with regulatory standards and internal labeling requirements.
• Experience with e-labeling applications and/or content management system applications (preferred).
• Fluent in graphic design software and/or desktop publishing software.

Compensation & Eligibility

• Pay Range: $145,000 - $170,000 a year (For US-Based Candidates Only).
• Work Authorization Status: Citizen / Permanent Resident.
• For this role, the anticipated base pay range is $145,000 - $170,000 per year.
• Plus eligibility for an annual bonus and equity (RSUs).

Understanding PROCEPTs 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 doesnt happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procepts 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 wont 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 PROCEPTs 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
• 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 ranges for this role represent 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 an annual performance bonus, equity, and the benefits listed above.

Work Environment We will 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.

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