Company Description
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.
Job Description
Primary Function of Position:
As a Regulatory Affairs Manager - Project Management, your primary function will be to facilitate seamless collaboration between post market and premarket regulatory activities while utilizing project management skills. You will work closely with stakeholders to ensure timely execution of projects/response to inquiries. Additionally, you will provide support to the Sr. Regulatory Affairs Director in addressing internal and external information requests related to premarket or postmarket activities
Roles and Responsibilities:
Main activities
- Coordinate and facilitate communication and information flow between post market and premarket regulatory activities.
- Respond to the inquires for MDD/MDR requirements
- Engage with cross-functional teams, including R&D, Quality Assurance, and Clinical Affairs, to gather and integrate relevant data for regulatory submissions.
- Support the implementation of risk control measures and strategies for product development and post-market surveillance.
- Collaborate with stakeholders to identify potential risks, assess their impact, and develop mitigation strategies.
- Ensure regulatory compliance by maintaining knowledge of applicable regulations and standards.
- Assist in the preparation and submission of regulatory documentation and reports.
- Utilize project management skills to plan, execute, and monitor regulatory projects.
- Provide assistance to the Sr. Regulatory Affairs Director in addressing internal and external information requests for premarket or postmarket activities.
- Actively engage in process improvement initiatives to streamline and optimize the regulatory process and procedures.
- Expertly navigate through technical documentation and other materials related to the CE marking of Initiative’s Medical Devices, in accordance with EU MDR
- Work closely with EU/CH Economic Operators to identify and escalate any deficiencies to the relevant subject matter experts (SMEs).
- Support reviews and approvals of A&P materials intended for the European market, ensuring compliance with local regulations and guidelines.
- Support key stakeholders, including Customer Service, Contract/Tender, and Sales teams, in responding to regulatory inquiries and providing accurate and timely information.
Additional activities
- Supports Quality Management system activities, 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.
- Supports process improvement and implementation of regulatory projects and tools.
- Assists and supports other employees, teams and field personnel as necessary.
- Other regulatory tasks and projects may be assigned as necessary.
Qualifications
Required Knowledge, Skills, and Experience:
Knowledge
- Have comprehensive knowledge of normative and regulatory requirements for medical devices, such as ISO 13485:2016, ISO 14971:2019, Directive 93/42/EEC, Regulation (EU) 2017/745 (MDR), and 21CFR820.
- Proven project management experience, including planning, execution, and monitoring of projects.
- Strong knowledge of regulatory requirements and risk management principles].
- Proficiency in regulatory affairs software and systems.
- Knowledge of Medical Device registration requirements in Europe and EUDAMED.
- Knowledge of product EU regulations or directives (e.g. RED, ROHS, Swiss MedDO, …).
- General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook).
Experience
- Minimum of 4 years of experience in regulatory affairs and 8 years of overall industry experience. A Bachelor’s or master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function).
Interpersonal skills
- Ability to navigate through technical documentation and independently identify deviations from internal processes.
- Demonstrate organizational and planning skills, including action oriented, focus urgency and driving for results, ability to manage multiple tasks simultaneously
- Proactive problem-solving skills and ability to work independently and in a team environment.
- Familiarity with process improvement methodologies and a continuous improvement mindset.
- Demonstrate good interpersonal skills, ability to work with others in international team and cross department environment.
- Excellent communication and interpersonal skills, with the ability to interact effectively with diverse stakeholders.
- Detail-oriented mindset, ensuring accuracy and attention to regulatory details.
- Orientation for work result details, with emphasis on accuracy and completeness
- Fluent in written and spoken English.
- Strong attention to detail and ability to analyze complex information and regulatory requirements.
Preferred Knowledge, Skills, and Experience:
- US FDA 21 CFR 803/806/820 basic knowledge would be a plus
Additional Information
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: 10% of the time
