Intuitive Surgical Careers

Sr Regulatory Affairs Specialist - Switzerland

Switzerland-Aubonne, Switzerland
Regulatory and Quality


Job Description

Job: Regulatory and Quality
Primary Location: Switzerland-Vaud-Switzerland-Aubonne
Schedule: Full-time
Requisition ID: 183602

Description

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
 
Primary Function of Position:

CE Marking, Regulatory registrations/filings, liaison with Corporate RAQA teams, Labeling, Promotional material, Clinical Affairs
 
Roles and Responsibilities:
 
Main activities
  • Prepare and submit Medical Device registration dossiers for assigned geographies
  • Provide regulatory support for new product development projects as assigned with focus on CE marking (under MDD as well as MDR).
  • Support preparation of technical documentation for submission to and review by Notified Bodies, as required (both MDD and MDR).
  • Provide regulatory support for life cycle management or clinical affairs/investigation projects as assigned.
  • Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.
  • Perform Regulatory Change assessments as assigned.
  • Perform Labeling and Promotional Material Reviews as assigned.

 

Additional activities

  • Implements and supports Quality Management System activities such as CAPA, documentation, training, management review, audit
  • Other regulatory tasks and projects may be assigned as necessary
Qualifications

Required Knowledge, Skills, and Experience:
 
  • Strong knowledge of the European Medical Device Directive 93/43/EEC and ISO 13485 requirements
  • Good knowledge of medical device registration (France, Switzerland, …) or promotion requirements in Europe
  • Significant experience in design control, including new product development
  • 6-7 years of experience in a regulatory affairs department
  • 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, focus urgency and driving for results.
  • Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams.
  • Ability to work autonomously, exercise daily judgment based on above regulatory knowledge
  • Orientation for work result details, with emphasis on accuracy and completeness
  • Fluent (C1 minimum) in written and spoken English
  • General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
 
Preferred Knowledge, Skills, and Experience:
 
  • US FDA 21 CFR 803/806/820 and EU Medical Device Regulation (2017/745/EU) knowledge would be a plus.
  • Clinical Affairs regulation (ISO 14155, MEDDEV 2.7-1 rev 4) knowledge and clinical study experience would be a plus