Product Compliance & Post-Market Surveillance Specialist - English Fluent 100 %
12.07.2019 | Employee | 100%



For our pharmaceutical partner based in Canton de Vaud, we are looking for a

Product Compliance & Post-Market Surveillance Specialist - English Fluent
100 % - Temporary Contract

...

Product Compliance & Post-Market Surveillance Specialist - English Fluent 100 %



For our pharmaceutical partner based in Canton de Vaud, we are looking for a

Product Compliance & Post-Market Surveillance Specialist - English Fluent
100 % - Temporary Contract

Your mission

Manage product complaint and post-market surveillance activities on a global basis for ACIST products.
Ensure compliance with global requirement for complaints, adverse event reporting and post-market surveillance.

Your responsibilities

  • Monitor and manage the overall complaint processing work flow to ensure timely processing of complaints.
  • Review complaints and assess for reportability and potential impact to patient safety and business operations.
  • Identify complaints requiring investigation and coordinate cross-functional tasks to facilitate complaint investigations.
  • Communicate with internal staff, field staff and global partners as required to support complaint activities.
  • Review complaint documentation to ensure that all required activities are properly completed and documented prior to complaint closure.
  • Respond to customer inquiries regarding product complaint and resolutions and prepare customer communications for specific complaints as required.
  • Conduct cross functional complaint meetings at regular intervals to provide a forum for complaint resolutions.
  • Maintain complaint handling procedures in accordance with the FDA quality system regulation, ISO 13485 and the applicable regulatory requirements.
  • Monitor complaints for adverse trends and report as necessary.
  • Provide complaint data for ongoing reports and in response to internal requests.
  • Generate complaint trending reports for analysis.
Your profile
  • 2-4 years medical device industry experience in Customer Support or Complaint Handling
  • BA or BS degree or a combination of education and experience providing equivalent knowledge
  • Working knowledge and experience with quality systems regulations and guidelines, ISO 13485, and FDA quality system regulations 21CFR 820.
  • Ability to read, analyze and interpret common scientific, technical journals, regulatory communications and complaint data.
  • Ability to respond to common inquiries or complaints from customers,
  • Ability to develop clear, concise, and timely oral and written reports.
  • Demonstrated proficiency with Microsoft Excel.
  • Well Organized and multitasking capabilities
  • English excellent.
  • Experience or knowledge of filing MDRs and international vigilance reports.
  • Communicate effectively and tactfully with all levels of personnel.
  • Mental demands - work is detail oriented, often with multiple priorities.  The environment is deadline sensitive and may be exposed to high-pressure situations. 
Your contact at Kelly Scientific
Amina Ouméziane 
Consultant Professional Staffing Life Science
 

12.07.2019
Employee, 100%

Contact

Kelly Scientific Genève
Amina Oumeziane
Rue du Rhône 114
1204 Genève
Fax: +41227371213
This website uses cookies to ensure you receive the best service. Further information can be found in our Terms and Conditions and in the Privacy Policy.