RAQA Specialist - maternity cover - 9 months

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:

The Regulatory Affairs and Quality Assurance (RAQA) Specialist provides support to the Sr RAQA Manager EU in the surveillance of European region (EU, CH and UK) regulatory requirements and ensure full compliance to these requirements by their integration into the appropriate RAQA process and documentation.

Roles and Responsibilities:

• Coordinate the European region customer inquiries, review KPIs and propose improvement actions.
• Support any EU process and QMS activities, including implementation of any new regulatory requirements.
• Support management and action implementation for Quality plans developed in the EU region (EU, UK, CH) or any other Quality improvement project.
• Perform the regulatory surveillance of any new regulatory requirements across the regions in charge
• Ensure Intuitive Economic Operator are properly identified, and the processes are in place to ensure regulatory compliance.  
• Supports the preparation and hosting of QMS audits.
• Provides regulatory review for proposed promotional materials, multi-media postings and customer letters
• Support other department activities, as appropriate (as back up) including Verification of compliance, RAQA support for tenders, management review preparation

Qualifications

Required Knowledge, Skills, and Experience:

• Good knowledge of the UK Medical Device Regulation 2002, European Medical Device Directive 93/42/EEC, the EU Medical Device Regulation (EU) 2017/745 and the CH Medical Devices Ordinance (MedDO SR 812.213 of July 1, 2020 & amendment of May 19, 2021),
• Experience of regulatory surveillance and assessment interpretation of regulations.
• Experience of ISO 13485 requirements, GMP and DOP/Work Instruction creation and maintenance
• Knowledge of STED (Summary of Technical Documentation).
• 2-3 years of experience in a medical device regulatory affairs department and Quality Management System based activities
• A bachelor’s or master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
• Demonstrate organizational and planning skills, including action oriented, focused urgency and driving for results
• Experience in working effectively in cross-functional teams across a global organization
• Ability to work autonomously, exercise daily judgment based on above regulatory knowledge
• Orientation for work result details, with emphasis on accuracy and completeness
• Fluent (C2 minimum) in written and spoken English
• General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Smartsheet, Outlook)

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.

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