SENIOR RA MANAGER MEDICAL DEVICES

☞ gloor & lang Pharma and Biotech Recruiting

View: 152

Update day: 25-04-2024

Location: St. Gallen St. Gallen SG

Category: Executive management

Industry: Chemical Manufacturing Staffing Recruiting Pharmaceutical Manufacturing

Position: Associate

Job type: Full-time

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Job content

Technology Consulting - CE marking - Technical File

Our customer is a renown technology consulting company with remarkable presence in technical industry segments in Switzerland. Strong Business Development for Medical Device Consulting Services allow to strengthen the teams for Regulatory and Quality Subject Matter Experts (SME). In the role of a Sr. Consultant you provide expertise, training and support in all issues regarding medical device regulations (MDR) for CE marking or FDA approval processes.

Your Challenges
  • Contribution in compiling technical documentation for submission dossiers
  • Accompany and advise Conformity Assessment by Notified Body
  • Technical Support of regulatory submission processes for medical devices
  • Lead cross-functional regulatory projects in a proactive, engaging and efficient way in conjunction with internal and external functions
  • Drafting of regulatory and quality documents required for health authorities or notified bodies
  • Review and development of technical files and support for QA documentation
Thrilling new products with innovative software and/or hardware engineering elements will be filed for approval to get launched shortly. In this context, we are looking for an experienced and versatile Sr. RA manager to support a growing team with expertise and farsightedness so as to cover a wide range of RA topics that will arise along the way to the set goal.

Your Experience
  • Technical or scientific university degree
    • 7-10 years of in-depth RA experience in medical devices
  • Registration of novel medical devices, ideally with software elements
  • Potential insight in international RA activities, primarily in Europe and North America (CE marking, 510(k), de novo…)
  • CE marking for medical devices with notified bodies
  • Excellent command of written and oral English, German is a strong asset Ready for a challenge with high impact and regional/global complexity? You will join a pleasant team, where your ideas and contributions will be valuable and much appreciated!
Interested? We are looking forward to get in touch with you.
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Deadline: 09-06-2024

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