Position: Entry level

Job type: Full-time

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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 theirmost 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

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 Specialist supports the department by converting/creating the Medical Device Technical Documentation according to the EU Medical Device Regulation (MDR), evaluating medical device changes, determining and executing registration strategy and ensuring compliance of marketing material according to internal processes.

Roles And Responsibilities

Main activities
  • Prepares and submits medical device technical documentation according to EU MDR requirements
  • Assesses the regulatory impact for the development of new devices or the changes to existing products
  • Coordinates registration strategy with sales/marketing stakeholders
  • Prepares and submits Medical Device registration dossiers for assigned geographies and ensures accurate records
  • Replies regulatory inquiries to key stakeholders (e.g. Customer Service, Contract/Tender, Sales)
  • Performs regulatory review of marketing material (e.g. brochures, presentations) for compliance to assigned geographies regulations
Additional activities
  • Supports Quality Management system activities such as CAPA or internal & external audits as needed
  • Supports process improvement and implementation of regulatory projects/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
  • Good knowledge of medical device registration (France, Switzerland, Slovakia, …) or promotion requirements in Europe
  • knowledge of product EU regulations or directives (e.g. RED, ROHS, Swiss MedDO, …)
  • General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
  • Experience
  • 3-5 years of experience in a medical device 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 translate technical documentation into effective regulatory documentation
  • 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
  • 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
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 : None

220164
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Deadline: 05-05-2024

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