Intuitive Surgical Careers

Regulatory Affairs Tender & Intelligence Sr manager - Aubonne - Switzerland

Vaud, Switzerland
Clinical Affairs


Job Description

Job: Clinical Affairs
Primary Location: Switzerland-Vaud
Schedule: Full-time
Requisition ID: 190778

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:


Regulatory Surveillance, advocacy with government bodies and manufacturer associations across Europe, implementation of new regulation, tender management


Roles and Responsibilities:


 

Main activities


  • Develop & implement regulatory intelligence and regulatory surveillance strategies to ensure full awareness of regulation affecting the company operations

  • Advise and influence operational decisions accordingly

  • Develop long range regulatory, quality or compliance projects together with the corporate headquarters to ensure implementation of applicable regulation and guidelines

  • Represents Intuitive Surgical with the European trade associations to

    • ensure that compliance interpretations are obtained, understood and appropriately communicated and documented in internal procedures.

    • carry out Intuitive Surgical advocacy activities (in Intuitive Surgical’s name or through trade associations) to defend and promote company policy objectives

  • Partner with domestic and international teams to respond to public tenders requirements

 

Additional activities


  • Implements and supports Quality Management System activities such as CAPA, documentation, training, management review, audit

  • Other regulatory projects may be assigned as necessary

  • Travel: up to 30%


Qualifications

Required Knowledge, Skills, and Experience:


  • At least 10+ years’ experience in medical device industry operating according to US or EU regulation including at least 3 years in regulatory affairs and quality assurance



  • A Bachelor degree, Engineering or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)

  • In-depth knowledge of EU MDD 93/42/EEC, EU MDR 2017/745/EU, US FDA CFR 21, ISO 13485

  • significant experience (typically >3 years) representing the company to external regulatory agenciesStrong interpersonal skills with ability to lead projects autonomously and to collaborate effectively with various scientific and business representatives in international team environment

  • Ability to foresee regulatory challenges and develop critical concepts and methodologies to overcome these

  • Team management experience of small team size associated with goals objectives definition / people development

  • Demonstrated autonomy, organizational and planning skills, including action oriented and can-do attitude, focused urgency and driving for results

  • Excellent verbal and written communication and presentation skills, ability to distill complexity and provide clear and actionable direction

  • Orientation for work result details, with emphasis on accuracy and completeness

  • Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
  • Language: Fluent English and French or German


Preferred Knowledge, Skills, and Experience:


  • Regulatory Affairs Certification (RAC) is a plus

  • Environmental regulation knowledge (REACH, ROHS, WEEE)