\\nCompany 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 and Quality Assurance Specialist, you will play a key role in ensuring compliance with the EU Medical Device Regulation (EU MDR), Swiss Medical Devices Ordinance (Swiss MedDO) and pertinent regulatory frameworks.

Roles and Responsibilities:

Main activities

• Conduct complete assessments of our medical devices\\\' compliance with the EU MDR and Swiss MedDO on behalf of EU/CH Economic Operators (VoC = Verification of compliance).
• Expertly navigate through technical documentation and other materials related to the CE marking of Intuitive\\\'s Medical Devices, in accordance with EU MDR and Swiss MedDO requirements.
• Work closely with EU/CH Economic Operators to identify and escalate any deficiencies to the relevant subject matter experts (SMEs).
• Plan and execute periodic verifications, ensuring timely follow-up on pending actions.
• Coordinate with the CE marking Team to organize future verification activities and ensure a smooth release of new products or design changes.
• Support Regulatory Surveillance process with regards to local EU regulation(s); support RA intelligence and regulatory surveillance process
• Supporting commercial business for customer inquiries for France and Benelux region
• Conduct detailed reviews and approvals of A&P (Advertisement and Promotion) materials intended for the European market, ensuring compliance with local regulations and guidelines.
• Provide guidance and training to the EU Marketing team on regulatory requirements and best practices related to A&P materials.
• Support key stakeholders, including Customer Service, Contract/Tender, and Sales teams, in responding to regulatory inquiries and providing accurate and timely information.
• Actively engage in process improvement initiatives to streamline and optimize the regulatory process and procedures.

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

• Good Knowledge/understanding of the EU Medical Device Regulation (EU) 2017/745 and European Medical Device Directive 93/42/EEC.
• Knowledge of Medical Device registration requirements in Europe and EUDAMED.
• Knowledge of product EU regulations or directives (e.g. RED, ROHS, Swiss MedDO, \\xe2\\x80\\xa6).
• General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook).

Experience

• 3-5 years of experience in a Medical Device Quality or regulatory affairs department.
• 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.
• 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.
• Orientation for work result details, with emphasis on accuracy and completeness
• Fluent (C1 minimum) 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.\\n \\n \\n \\n \\n \\n

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