Vice President Global Regulatory Affairs
Vice President Global Regulatory Affairs
Posted on :
11-04-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
Company Overview
Embark on an enriching journey with PROCEPT BioRobotics where our vision mission and values guide everything we do as a company. We 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:
As PROCEPT BioRobotics continues to evolve and expand its global footprint we seek a worldclass regulatory executive to serve as Vice President (VP) of Global Regulatory Affairs (RA). This role will report into the SVP of Global RAQA. This leader will architect and execute a forwardlooking comprehensive regulatory strategy supporting PROCEPT BioRobotics complex surgical robotics portfolioincluding oncology applications such as prostate cancerand other emerging technologies. The successful candidate has a proven track record guiding diverse crossfunctional teams to regulatory success in multiple global jurisdictions while fostering a culture of compliance agility and innovation.
This role will assume full responsibility for both strategic and operational RA initiativesdriving regulatory submissions and approvals cutting edge regulatory intelligence global market entry and postmarket compliance. The ideal candidate has at least two years of prior VPlevel experience excels at onboarding different or emerging technologies and possesses excellent writing skills and robust knowledge of clinical hardware and software components. Experience with complex product categories including software releases including artificial intelligence/machine language (AI/ML) functions oncologyfocused submissions (e.g. prostate cancer) and PMAlevel submissions in surgical robotics is highly desired.
What Your DayToDay Will Involve:
- Below are the areas of strategic importance that youll be able to focus on in this role.
- Develop refine and maintain an agile global regulatory infrastructure and regulatory intelligence to address evolving market and compliance demands
- Oversee robust US and global regulatory strategies (e.g. FDA 510(k) PMA IDE EU MDR) that align with PROCEPT BioRobotics complex surgical robotics and associated accessories including oncologyspecific indications such as prostate cancer. Lead softwarebased submissions that support AI/ML related functionality
- Provide expert guidance on strategic operational and budgetary planning to optimize regulatory pathways and timelines for new technologies and oncologyrelated device submissions
- Work closely with R&D Quality Legal Marketing Manufacturing Operations and Clinical teams to synchronize product development and global regulatory submissions ensuring alignment with corporate objectives
- Engage with leadership and board members on evolving regulatory requirements effectively articulating opportunities risks and strategies
- Guide PROCEPT BioRobotics in onboarding and integrating new or emerging technologies ensuring compliant product development cycles and swift market entry. This includes but is not limited to supporting the implementation of global distribution agreements for adjacent technologies that complement PROCEPT BioRobotics product portfolio
- Be a leader that embodies the ExCITED values of PROCEPT BioRobotics
- Build mentor and lead a highperforming global RA team; cultivate a pipeline of future leaders through professional development and succession planning
- Establish clear performance metrics and a structured framework for training and ongoing skill enhancement.
- Ensure resource allocation (budgeting staffing and talent management) meets corporate growth objectives.
- Serve as the primary liaison with FDA notified bodies and other regulatory authorities; nurture constructive transparent and credible agency relationships
- Drive all aspects of domestic and international product registrations submissions and renewals with emphasis
- Support postmarket surveillance vigilance and MDR reporting processes
- Enhance and maintain the regulatory management system aligning it with PROCEPT BioRobotics dynamic business goals and quality management system (QMS)
- Develop implement and update policies and procedures to ensure adherence to local national and international regulations and certification standards
- Establish best practices and key performance metrics for optimizing submission cycle times and improving approval outcomes
- Review and advise marketing on labeling product claims promotional materials press releases training documents and complaints to ensure regulatory and legal compliance
- Coordinate strategic planning and regulatory input for clinical trials including supporting oncologyspecific indications (e.g. prostate cancer) ensuring data supports pivotal submissions
- Provide authoritative guidance on risk management data integrity and documentation standards for all regulatory filings
- Build a strong regulatory intelligence program to monitor interpret and respond proactively to emerging global regulations standards and industry trends particularly in software driven AI/ML related hightech medical robotics and oncology
- Lead or participate in internal committees task forces and special projects championing initiatives to streamline regulatory processes and deliver corporate agility
- Ensure full compliance with PROCEPT BioRobotics Quality Policy EHS Policy and any relevant local state or federal regulations
- Maintain the highest standards of ethics integrity and accountability throughout all regulatory processes and communications.
- Directly supervises employees in the Regulatory Affairs Department in accordance with PROCEPT BioRobotics policies and applicable laws.
- Interviewing hiring and training employees
- Planning assigning and directing work
- Appraising performance; rewarding and disciplining employees
- Addressing complaints and resolving problems
Regulatory Leadership & Strategy
CrossFunctional Collaboration
Team Development & Management
Global Compliance & Submissions
Regulatory Systems & Policies
Stakeholder Communication & Support
Innovation & Continuous Improvement
Corporate Compliance
Supervisory Responsibilities
The Qualifications We Need You to Possess:
- BS/BA in a relevant scientific engineering or medical discipline; advanced degree (MS PhD or equivalent) strongly preferred.
- Minimum 20 years of progressive regulatory affairs experience in the medical device industry with at least 2 years in a VP or equivalent senior leadership role.
- Demonstrated excellence in managing complex regulatory submissions and approvals (e.g. for advanced surgical robotics (with AI/ML referred) and/or oncologyrelated devices); experience in global markets (EU Japan China)
- Outstanding writing and communication skills evidenced by successful authorship of critical regulatory submissions briefing documents and formal responses
- Proven history of collaborating with clinical teams including oversight of IDEs or clinical trials supporting oncologyfocused regulatory filings; prostate cancer experience is highly desirable
- Track record of onboarding different or emerging technologies into an existing portfolio and expediting their path to market
- A recognized leader in the regulatory community with a network of industry and agency contacts
- Deep understanding of FDA regulations ISO standards EU MDR and other relevant global regulatory frameworks
- Solid background in complex device ecosystems including hardware/software integration; experience in roboticassisted surgical devices strongly desired
The Qualifications We Would Like You to Possess:
- Experience in successfully using predetermined change control plan (PCCP) in submissions is desirable
- Exceptional teambuilding abilities and a passion for developing talent across geographically distributed teams
- Skilled at influencing internal and external stakeholders including top executives board members and regulatory authorities
- Adept at balancing risk management with the need for timely and innovative product development.
$261524 $307675 a year
Compensation will also include a bonus of 35 and equity at offer.
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 crossfunctional team building an immersion in Procepts history jampacked interactive sessions with executive leadership and a crashcourse in the mission and purpose of what we do. It continues with our oneofakind 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 onsite gym a 401(k) plan with employer match shortterm and longterm 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 noncommissionable roles or ontarget earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to jobrelated 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
Well 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.
Required Experience:
Chief
Employment Type
Full-Time
Key Skills
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