Regulatory Affairs Lead - Temporary position
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Primary Function of Position:
The Regulatory Affairs Lead plays an important role in directing the regulatory team's efforts, focusing on New Product Development (NPD) and sustaining activities within designated Business Units. This role demands a deep understanding of regulatory compliance frameworks and strategic direction within the EU. The Regulatory Affairs Lead is responsible for ensuring the alignment of regulatory strategies with company objectives, leading to successful product launches and changes. The Regulatory Affairs Lead is central to fostering an environment of excellence and innovation, guiding the team through the regulatory landscape, and ensuring that products meet stringent regulatory standards.
Roles and Responsibilities:
Main activities
- Lead Regulatory Team efforts in support of NPD projects and sustaining operations within specified Business Units, acting as a primary point of contact for regulatory matters and ensuring regulatory compliance and strategic innovation.
- Develop and communicate comprehensive EU regulatory strategies for projects, guiding team members through the development and implementation process.
- Oversee the preparation and coordination of EU submissions for Medical Devices, securing timely regulatory clearances for new products, new indications, and product changes.
- Mentor team members in the creation and execution of CE Mark submissions and change notifications to our Notified Body (NB), including strategy development for responding to regulatory inquiries.
- Direct the preparation of CE Mark documentation for EU submissions related to NPD projects and product changes, ensuring thorough review before RA Management approval and NB submission.
- Ensure the completion and maintenance of Technical Documentation for CE Mark, adhering to regulatory requirements and best practices.
- Engage with Notified Bodies and Competent Authorities, representing the company's regulatory strategy and fostering positive relationships.
- Offer expert advice to cross-functional teams, interpreting and translating complex regulatory requirements into actionable strategies.
- Stay ahead of regulatory and standards changes, proactively updating company policies and procedures to maintain compliance.
- Initiate and lead process improvement projects to enhance the efficiency and effectiveness of regulatory procedures.
- Support the growth and skill development of team members, contributing significantly to the Regulatory Affairs department's continuous improvement.
- Provide performance review input for Regulatory Affairs Team members, acknowledging contributions and guiding professional development.
Additional activities
- Assists in the implementation and maintenance of the Quality Management System, such as CAPA, Management Review and audits
- Participates in internal/external audits and inspections, and ensures that company procedures, processes and documentation meet the requirements of the Quality Management System, ISO 13485 and other applicable regulations
- Provides regulatory support to other departments such as R&D, engineering and clinical affairs as needed
- Other regulatory tasks and projects may be assigned as necessary.
Required Knowledge, Skills, and Experience:
- At least 12+ years of significant experience in regulatory affairs and quality compliance within the medical device sector, with a strong focus on adherence to EU regulations.
- A Bachelor's or Master's degree in Engineering, Medical Technology, or a closely related field is highly preferred, though equivalent practical experience in a similar role may be considered.
- Profound understanding of global medical device regulations, including ISO 13485, the European Medical Device Directive (93/42/EEC), and the Medical Device Regulation (2017/745/EU), ensuring comprehensive compliance across projects.
- Demonstrated ability to independently determine methods and procedures for new or special assignments, coupled with the capability to supervise the work of team members effectively.
- Significant expertise in design control and experience managing EU submissions for NPD projects and sustaining activities.
- Familiarity with specific EU regulations and directives relevant to product compliance, such as RED, ROHS, and the Waste Framework Directive, among others.
- Demonstrate strong organizational and planning skills, with a proactive approach to problem-solving, a sense of urgency, and a commitment to achieving results.
- Excellent interpersonal abilities, with proven success working collaboratively within international teams and engaging effectively across departments.
- A meticulous attention to detail, ensuring accuracy and completeness in all work-related tasks.
- Fluent in English, with a minimum of C1 level proficiency in both written and spoken forms, to facilitate clear and effective communication.
- General computer proficiency, including familiarity with Microsoft Office Suite (Word, Excel, PowerPoint) and Outlook, to support daily operations and communication.
Preferred Knowledge, Skills, and Experience:
- Knowledge of US FDA 21 CFR 820.30 and 510(k)
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Shift: Day
Travel: None
