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Post market Surveillance Manager (m/f/d) (EN)

[14361]
Quality, Regulatory Affairs

Job title: Post market Surveillance Manager (m/f/d) Industry: Medical Devices Skills: Quality, Regulatory, PMS, ISO 13485 Start date: ASAP Location: Basel, Switzerland   The Aristo Group is a Recruitment focused solution provider in the life sciences industry. Our goal is to find the “perfect match” for our customers and candidates. We are now looking for an experienced Post Market Surveillance Manager to join a Global MedTech company to work on innovative products benefiting the healthcare of millions.     Main duties ·Ensure compliance of the Post Market Surveillance processes with pertinent legal and regulatory standards. ·Establish and execute a schedule for PMS Reports/Periodic Safety Update Reports ·Work alongside the cross-functional PMS team to develop and release PMS Reports. ·Assist Design & Development teams by promptly providing necessary PMS insights. ·Provide relevant contributions to management processes such as Corrective and Preventive Actions (CAPA) and Management Reviews. ·Have a comprehensive understanding of input/output processes including Complaint Handling, Adverse Event Reporting, Field Safety Corrective Actions, and Risk Management, and offer support as needed.     Qualifications ·3 years’ experience in Quality Management or regulatory affairs in Medical Device Industry ·Trained in Quality Management and Quality Systems with expertise in Post Market Surveillance (PMS) requirements, including mandated authority reporting such as ISO 13485, EU MDR 93/42 EEC, and QSR. ·Possesses robust analytical skills, with a preference for experience in statistical analysis. ·Fluent in English   For further information about this position, please apply with your CV or contact me directly via linkedIn.   *Please note, only those with the right to work in Switzerland can apply*

Job title: Post market Surveillance Manager (m/f/d)

Industry: Medical Devices

Skills: Quality, Regulatory, PMS, ISO 13485

Start date: ASAP

Location: Basel, Switzerland

 

The Aristo Group is a Recruitment focused solution provider in the life sciences industry. Our goal is to find the “perfect match” for our customers and candidates.

We are now looking for an experienced Post Market Surveillance Manager to join a Global MedTech company to work on innovative products benefiting the healthcare of millions.

 

 

Main duties

  • Ensure compliance of the Post Market Surveillance processes with pertinent legal and regulatory standards.
  • Establish and execute a schedule for PMS Reports/Periodic Safety Update Reports
  • Work alongside the cross-functional PMS team to develop and release PMS Reports.
  • Assist Design & Development teams by promptly providing necessary PMS insights.
  • Provide relevant contributions to management processes such as Corrective and Preventive Actions (CAPA) and Management Reviews.
  • Have a comprehensive understanding of input/output processes including Complaint Handling, Adverse Event Reporting, Field Safety Corrective Actions, and Risk Management, and offer support as needed.

 

 

Qualifications

  • 3 years experience in Quality Management or regulatory affairs in Medical Device Industry
  • Trained in Quality Management and Quality Systems with expertise in Post Market Surveillance (PMS) requirements, including mandated authority reporting such as ISO 13485, EU MDR 93/42 EEC, and QSR.
  • Possesses robust analytical skills, with a preference for experience in statistical analysis.
  • Fluent in English

 

For further information about this position, please apply with your CV or contact me directly via linkedIn.

 

*Please note, only those with the right to work in Switzerland can apply*

map Basel, Switzerland date_range 13.03.2024 update Permanent
Direct contact

Antony Polito

Senior Recruitment Consultant
mail a.polito@aristo-group.ch
phone +41 44 27439 00


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